Let's Talk Quality

What does it really take to build a quality organization from the ground up - and do it again, and again, across multiple companies? Laura Singer on building quality that scales.In today's episode I was joined by Laura Singer, Vice President of Quality and Compliance at Loyal. I really wanted to speak to Laura because she has spent the better part of two decades walking into an early-stage biotech and building everything from scratch. Each time, a different product, a different regulatory landscape, a different team. And each time, the same fundamental challenge: how do you build quality infrastructure that is fit for today, but will not break tomorrow?Laura's career is a study in what it means to grow as a quality leader. She started in quality systems, realized she wanted more breadth, and made a deliberate move into a full GXP leadership role at Amicus as VP of Quality - a company that was developing its first commercial product for a rare disease. She came in as a senior director, proved herself, and earned the VP title. From there she spent six years at Heron Therapeutics building out an international quality function, and has since continued that pattern in successive roles.What makes Laura a compelling guest is not just the technical expertise - it is her philosophy. She talks about quality not as a compliance function, but as a business partner. She talks about leadership not as direction-giving, but as creating the conditions for other people to own their work. And she talks about the job of a quality head at the executive level with unusual clarity: you walk in with a plan, you are calm, you translate the regulations for the people around you, and you do not retreat when things go wrong.We talk about the following:• What it means to find your niche as a quality leader and how Laura discovered hers• Making the leap from a specialist quality systems role to a full GxP VP position without a network inside the company• How to communicate with a C-suite and executive team as a quality leader - and where most people get it wrong• What actually breaks in a quality system when a company scales from 40 to 140 people• How to define inspection readiness in practice, including the CDMO piece that often gets underestimated• Leadership philosophy, hiring for fit, and the importance of executive presence in qualityLaura is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a qualityprofessional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.Thank you Laura for sharing your incredible journey. Hope everyone enjoys the show.WHO THIS EPISODE IS FOR• Quality leaders at VP and SVP level who are navigating the transition from compliance-focused to business-aligned quality leadership• Heads of Quality at early-stage biotechs who are building or scaling their quality function for the first time• Senior Directors and Directors of Quality who are ready to make the step up to VP and want to understand what that leap really looks like• Quality professionals at any level who want to build stronger relationships with their C-suite and executive team• Anyone in the life sciences who wants to understand what good quality leadership actually looks like in practice

From the lab bench to the C-Suite - and every crisis in between.In today's episode I was joined by Kimberly Garko, former Senior Vice President and Chief Technical Officer at Akebia Therapeutics.I really wanted to speak to Kim because her career trajectory is unlike almost anyone else I have interviewed on this show. She is a PhD virologist who began her career in the QC lab at Biogen, and over the following two decades built herself into one of the most accomplished quality and technical operations executives in the industry. She has led through warning letters, product recalls, complete response letters, workforce reductions, and commercial drug launches - often all at the same organisation. Her story is one of relentless curiosity, self-belief, and a genuine commitment to the patient at every stage.Kim talks about the pivotal moment early in her Biogen career when she was pulled out of the lab to help lead the effort to return Tysabri to market following its voluntary withdrawal. She discusses how that experience raised her ceiling permanently, and why she has never been able to go back to a smaller version of herself since. She shares how she thinks about building quality culture, identifying real leaders within an organisation, and what it actually takes to lead a team through a product recall at 3am on a Tuesday.We talk about the following:• How a JC virus safety crisis at Biogen changed the entire direction of Kim's career• What she looks for when she joins a new organisation and how she scales quality teams without losing culture• Her philosophy on 'creative compliance' and why the answer in quality is never just no• How to lead through warning letters, product recalls, and complete response letters without losing the team• The knowledge management crisis that follows every reduction in force and why most organisations are not prepared• What the Vafseo launch felt like after everything Akebia had been through• Her advice to quality leaders who want to reach the C-SuiteKimberly Garko is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in the most complex development environments imaginable. She has done this across biologics, oral solid dose, devices, and combination products at every stage from early clinical through to commercial launch.If you are a quality professional at any stage of your career - whether you are building your first team or trying to figure out what comes after VP - this episode is for you.Thank you Kim for sharing your incredible journey.Hope everyone enjoys the show.WHO THIS EPISODE IS FOR:• Quality leaders at director and VP level who are navigating high-pressure compliance situations and want a practical framework for crisis response• Aspiring quality executives who want to understand what it actually takes to move from functional leader to Chief Technical Officer• Quality managers in biologics, pharma, and biotech who want to build stronger, more resilient teams• Anyone who has ever had to manage a recall, a warning letter, or a workforce reduction and wants to hear from someone who has been through all three• Early-career scientists and QC professionals wondering whether there is a path to leadership from the lab bench

Three BLAs. Three companies. One industry-defining challenge.Jake Trees, Irving Ford, and Megan Callan on What It Really Takes to Cross the Commercial Line in Cell and Gene TherapyIn this special compiled episode of Let's Talk Quality, Hemish Ilangaratne brings together three quality leaders who have each led their organisation through one of the most demanding transitions in the industry: from clinical development to commercial manufacturing for a cell or gene therapy product.Jake Trees spent five years at Bristol Myers Squibb leading the quality function through the approval and launch of Abecma and Breyanzi, two of the first commercially approved CAR T cell therapies in the world. Irving Ford was the first quality hire at the Celgene cell therapy facility in New Jersey, built the QC organisation from nothing, and has since led quality through four BLA approvals across multiple cell therapy companies, most recently at Adaptimmune for the approval of Aucatzyl. Megan Callan is VP of Quality at Abeona Therapeutics, where she guided the quality team through the FDA approval of Zevaskyn, the first ever approved topical gene therapy for a rare genetic skin disorder.These are three distinct products, three distinct companies, and three distinct leadership journeys. But across all three conversations, the same themes surface: what it takes to build a quality team from scratch, how to shift the mindset of a clinical organisation towards commercial standards, and what the moment of approval actually feels like after years of sustained effort.In this episode, you will hear the following:Jake Trees on the setbacks on the road to BLA approval, including a refusal to file, cell growth failures during scale-up, and leading through a pandemic while hosting three health authority inspectionsIrving Ford on being the first quality hire at a new commercial cell therapy facility, building a team that grew to over 200 people, and why working in the gray is not a compromise but a core competency in this fieldMegan Callan on taking a quality team from five people to more than 60, coaching a clinical workforce into a commercial mindset, and what it means to empower people to make fast decisions when the patient is waitingThis episode is for anyone who is working towards a first commercial approval, scaling a quality function in cell or gene therapy, or trying to understand what it takes to lead through the most demanding regulatory and operational environment in modern pharma.Thank you to Jake, Irving, and Megan for sharing their journeys.Hope everyone enjoys the show.

The non-linear path is often the most powerful one.Cinta Burgos on Building a Career Across Functions, Modalities, and Mindsets.In today's episode I was joined by Cinta Burgos, Senior Vice President of Quality and Regulatory CMC at New Amsterdam Pharma.I really wanted to speak to Cinta because her career does not follow the path you might expect for someone at SVP level. She has moved across pharma, medical devices, and biologics, held roles in quality engineering, validation, regulatory, and consulting, and built her executive presence not through a linear climb but through curiosity, flexibility, and a willingness to take opportunities as they came.Cinta's journey began with a biophysics degree, a near-completed master's in mechanical engineering, and early laboratory work on human growth factors and the varicella zoster vaccine. Life changed direction more than once - moving across the country, starting a family, building a consulting practice that spanned 17 years - and through each transition, she added a new dimension to her expertise. Today she leads quality assurance, quality control, quality systems, and CMC regulatory at a company she describes as scientifically driven, ethically led, and genuinely exciting.What stands out about Cinta is her philosophy of leadership. She talks about moving from task-oriented thinking to big-picture ownership, about not micromanaging the talented people around you, and about the importance of keeping a personal board of directors - mentors you check in with at different stages of your career. She is also candid about the moments where she did not immediately see an opportunity for what it was, and honest about what that taught her.We talk about the following:- How a biophysics background and an unfinished master's became an asset in a 30-year career- Why Cinta moved from R&D to validation to quality and what each transition taught her- The value of 17 years in consulting and the leadership jump it created- How quality professionals can move from task-oriented contributors to big-picture leaders- The role of AI in quality and manufacturing, and why human oversight is non-negotiable- Why quality voices are still largely absent from board-level conversations- What it means to treat everyone in your company as a quality professionalCinta Burgos is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.Thank you Cinta for sharing your incredible journey.Hope everyone enjoys the show.

From a graveyard shift in a generic drug lab to leading quality for one of the most advanced cell therapy programs on the planet - Mike Ruane's story is one every quality professional needs to hear.In today's episode I was joined by Mike Ruane, Head of Quality for In Vivo CAR-T at Bristol Myers Squibb.I really wanted to speak to Mike because his career is one of the more fascinating journeys I have come across in quality leadership. He has spent nearly two decades within what is effectively the same organisation, yet has lived through multiple acquisitions, spin-offs and complete pivots in therapeutic modality - each time emerging in a stronger, more interesting role than before.Mike began his career at APP Pharmaceuticals on a midnight QC shift, testing in-process samples on a graveyard schedule. From there, he followed the Abraxane asset into aBraxis Bioscience, built out supplier quality relationships across Central and South America, and eventually relocated from Chicago to New Jersey when Celgene consolidated its operations.That move opened the door to something entirely new - a CAR-T therapy program called BB2121 - a field Mike had never worked in and knew little about. Eight years later, he is now heading quality for in vivo CAR-T, one of the most cutting-edge modalities in all of biopharma.What makes Mike Ruane such a compelling guest is not just the breadth of his experience but his philosophy. He is a first-principles thinker who has thrived precisely because he never assumed the existing process was the right one. He asks the uncomfortable questions, encourages his team to do the same, and believes deeply that curiosity is the most underrated skill in quality.We talk about the following:How working in a lean generic drug environment early in his career shaped his mindset foreverNavigating multiple acquisitions and spin-offs within a single career arcWhat it takes to step into an entirely new therapeutic modality with no prior experienceWhy curiosity and asking the right questions is the real engine of career growth in qualityHow he interviews candidates and what most people get wrong when they are being interviewedMike Ruane is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.Thank you Mike Ruane for sharing your incredible journey.Hope everyone enjoys the show.

CAR-T Saved Her Life. Why Can't Most Patients Access It?In today's episode I was joined by Laurie Adami, cancer survivor, patient advocate, and one of the most impactful voices I've had on the podcast.I first spoke to Laurie a couple of years ago, and her episode is still one of the most listened to we've had.Laurie went through a 12-year cancer journey, six lines of therapy, multiple relapses, clinical trials… and ultimately, in 2018, her 7th treatment, CAR T-cell therapy which saved her life and finally for the first time in 12 years put her in a complete remission.Now, two years on, she's back.Still in a complete remission and requiring no further treatment nearly 8 years post CAR T infusion, Laurie is now considered cured even though her cancer is still labeled incurable.But what stood out to me in this conversation is that while the science has progressed… many of the systemic challenges patients face haven't.We talk about the following:· What life actually looks like after being “cured” of cancer· The long-term side effects of 12 years of treatment· Why most biotech and pharma professionals have never spoken to a patient· The reality behind “patient centricity” in the industry· Why 80% of eligible patients still can't access CAR-T therapy· The biggest bottlenecks in access - awareness and insurance· The financial burden of cancer treatment in the US· Where real progress is being made in cell and gene therapy· The future of CAR-T in autoimmune diseases and beyond· Laurie's memoir and why every biotech employee should read itThis is an honest conversation about the gap between scientific progress and real-world patient impact.A huge thank you to Laurie for returning to the show and tell her story again! The work she is doing to help raise awareness is inspiring, and I'd urge anyone to connect with Laurie and follow her journey.If you work in biotech, pharma, healthcare, or you'd like to learn more about the challenges this industry still faces… this is one you need to hear.

Perseverance, perspective and people-first leadership in a global quality role.In today's episode I was joined by Burak Begen, Head of Global Manufacturing Quality at Siemens Healthineers.I really wanted to speak to Burak because he's built his career across multiple countries, cultures and challenges, and now leads quality across global manufacturing sites. His journey gives a very real view of what it actually takes to operate at that level.Burak's career hasn't been linear or easy. From starting his career in Turkey, moving to the US for his PhD, rebuilding his career from scratch, and navigating setbacks like job losses and site closures - his story is defined by perseverance and resilience.What stood out is how those experiences shaped the way he leads today. He leads from the front, sets high standards, but always stays close to his teams. Whether it's staying late to close records or travelling globally to connect with people on site, his leadership is grounded in accountability and support.We talk about the following:Why perseverance is a defining trait for quality leadersLeading global teams across time zones and culturesBuilding a partnership mindset in quality instead of a “policing” approachCreating the right KPI culture and avoiding “watermelon metrics”Empowering teams to make decisions and building psychological safetyIf you are a quality professional managing multiple sites a leader struggling with KPIs, culture or engagement across sites, or someone who wants to step into a larger global role, then this episode is for you.Thank you Burak for sharing your incredible journey.Hope everyone enjoys the show.

Great quality leaders don't just build systems - they build people, culture and confidence.In today's episode I was joined by Melodie Bryce, Chief Quality Officer at Kincell Bio.Melodie's journey is a brilliant example of how diverse experience across manufacturing, supply chain, training and quality can shape a well-rounded quality leaderWhat stood out most is her approach to leadership. Melodie focuses heavily on building strong teams, developing future leaders and creating an environment where people are supported but also expected to take ownership. She combines high standards with a genuine commitment to coaching and mentorship.We talk about the following:· How to assess a quality organisation when you first join· Why hiring “stronger than you” is critical to building high-performing teams· What makes a great quality leader in fast-growing biotech environments· The importance of being a self-starter in quality roles· How to develop future leaders through coaching and mentorship· What to look for in the first two weeks of hiring someone· Leading through remediation and why it accelerates growth· Building a quality culture where everyone takes ownership· Balancing compliance with real-world decision making in cell therapy· Why “digging deep” is the foundation of leadership successMelodie is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.If you are a quality leader looking to develop stronger teams and future leaders, then this episode is for you.Thank you Melodie for sharing your incredible journey.Hope everyone enjoys the show.

If you are the first quality hire in a startup, your job is not to build everything at once.Your job is to build the right things first.That was one of the clearest takeaways from my conversation with Rex Ready on Let's Talk Quality.A few practical points he shared stood out:· Follow the path of the product· Understand the patient experience· Focus first on what directly affects patient safety· Build procedures around processes that already work· Prioritise quality investment based on stage, modality, and riskIn early-phase environments, it is easy to create a long list of things you would like to have.An EQMS. A fuller audit programme. More formal vendor oversight. A bigger team.All of that matters.But not all of it matters equally on day one.Strong quality leadership is about judgment. It is about knowing what must be in place now, what can come next, and how to build trust while you do it.That is especially true in cell and gene therapy, where complexity is high and patient impact is immediate.A very strong conversation with Rex, and a useful one for anyone building quality in a lean biotech environment.

Quality is changing. The systems are getting smarter, the data is getting bigger, and the people side is still the hardest part.This week, I sit down with Dennis Rodman, Senior Director of Quality Management Systems and Digital Compliance at Intellia Therapeutics.Dennis brings a rare perspective to quality. With 13 years at BMS across operations, technical services, and quality, he now helps a gene editing company prepare for its first commercial product.In this episode, we explore:Why quality should be value-add, not a compliance hammerWhat separates companies that get digital transformation right from those that don'tHow to choose the right QMS without getting sold something you don't needWhy AI isn't delivering the ROI people expected, and what's going wrongHow to manage change when most people don't want itWhat early-career quality professionals should be doing right now to accelerateA practical, honest conversation for anyone working at the intersection of quality, systems, and people.

From accidental quality professional to global quality leader - Valerie Brown's story is one of courage, curiosity, and conviction.In today's episode I was joined by Valerie Brown, Head of Global Quality Assurance and Compliance at Thermo Fisher Scientific's Clinical Research Group.I really wanted to speak to Valerie because she brings something different to the quality leadership conversation. Yes, she has held senior quality roles across innovator companies, CDMOs, and now one of the largest CROs in the world. But what makes her story compelling is how she got there - and what she learned along the way.Valerie didn't plan to work in quality. At 22, she was asked to be a scribe for an FDA inspection. The host fell ill on the day. She stepped in - no preparation, no safety net - and handled it.Someone told her she had a knack for it. She wasn't sure she agreed. She still wanted to be in the lab, in manufacturing, doing what she knew. But that moment planted a seed.What followed was a career that took her across CDMOs, innovator companies including Gilead Sciences, and now Thermo Fisher - where she leads global quality assurance and compliance for the clinical research group. She has sat on both sides of the table, as sponsor and as service provider, and that experience shapes everything about how she leads.We talk about the following:How Valerie accidentally became a quality professional, and why that unplanned start shaped everything that followedWhat it felt like to host an FDA inspection at 22, with no preparation and no safety netHer philosophy of servant leadership and what it really means to lead with empathy in a regulated environmentThe challenge of transforming a fragmented quality organisation into a connected, strategic function at Thermo FisherThe difference between working on the innovator side versus the CRO side - and the unique skill set the latter demandsWhy speed and quality are not in conflict, and how embedding quality by design from the outset actually accelerates deliveryHer approach to talent development - why she prefers to grow leaders from within and how she identifies that potential earlyThe growing importance of AI and digital governance in regulated environments, and why quality professionals need to engage with these tools nowWhat keeps her up at night heading into 2026 - from talent gaps to trial complexity to the pace of regulatory changeThe advice she would give her younger self, and what she believes every aspiring quality leader needs to understandValerie Brown is a highly accomplished global quality leader whose career is a masterclass in adaptability, influence, and patient-centric thinking. She leads with purpose, develops people with intention, and approaches every challenge with the mindset of a problem solver - exactly the kind of leader our industry needs more of.Thank you Valerie for sharing your incredible journey. Hope everyone enjoys the show!

What if the leader you become is shaped less by your title, and more by the life you've lived?In today's episode I was joined by Dana Adcock, Quality Consultant and former Senior Director of Quality Systems.I really wanted to speak to Dana because she brings something different to the quality leadership conversation. Yes, she has decades of experience leading global audit and quality systems teams. But what makes her story powerful is how openly she connects her personal journey to the leader she has become.Dana shares how growing up as an adult child of alcoholics shaped her early career. Avoiding conflict. Playing small. Hiring people who thought like her. Shying away from leadership roles despite being promoted into them.Over time, through personal hardship, therapy, motherhood, and reflection, she stepped into leadership differently. More intentional. More courageous. More authentic.We talk about the following:· How early life patterns show up in leadership behaviour· Why many capable professionals avoid management roles· Moving from conflict avoidance to confident, purpose-led leadership· Building diverse teams instead of hiring people “just like you”· The mindset shift that happened during her “midlife awakening”· How adopting her daughter Abby changed how she leads and advocates· The link between personal resilience and professional courage· Showing up authentically on LinkedIn and why it felt terrifying· What “living the fourth quarter intentionally” really means· Advice for quality professionals who feel pressure to hide parts of themselvesDana is a thoughtful, courageous and deeply reflective leader who demonstrates that strength in quality leadership isn't about technical authority alone – it's about self-awareness, integrity and the willingness to grow.Thank you Dana for sharing your incredible journey.Hope everyone enjoys the show!

In today's episode, Hemish was joined by Anthony Mire-Sluis, Head of Global Quality at Gilead.Tony because has lived quality from every angle - UK government and regulatory work, a stint at the FDA, and then senior global leadership roles in major pharma. That perspective is rare, and it shows in how he builds teams and drives change.Tony's journey is a brilliant example of how strong quality leadership is less about having all the answers, and more about building trust, listening properly, and creating systems that let people do their best work.He talks about the following:• How Tony's science background (immunology, genetics, and a PhD) shaped the way he leads quality• What 10 years in government taught him about great vs poor regulatory filings - and why he moved into industry• The difference between leading a US-centric quality organisation vs a truly global one• Why building a trusted leadership team is the non-negotiable for running global quality at scale• How Tony uses his first 90 days: listening, due diligence, and getting under the skin of the culture• Why he starts transformation from the shop floor - not from the senior leadership layer• Digital and AI in quality: fix the process first, then digitise (otherwise you just create a clunky digital version)• How to reduce firefighting and move quality from reactive to proactive - with better workflows and connected systems• Managing resistance to change and bringing people along early so adoption sticks• Advice for aspiring quality leaders: networking, knowing yourself, and broadening your experience across qualityAnthony Mire-Sluis is an authentic, people-first quality leader with a rare blend of regulatory depth and big pharma operational experience - and he's exactly the kind of leader who makes quality a true enabler of the business.Thank you Tony for sharing your incredible journey.Hope everyone enjoys the show!

In today's episode, Hemish was joined by Ed Armstrong and Jon Voss, two Quality leaders who've both worked across early-stage, clinical, and complex biotech environments.Ed and Jon share what they're seeing on the ground - from funding pressure and modality shifts, to how regulators are engaging, and where Quality leaders are gaining (or losing) influence.They talk about the following:The current state of pharma and biotech, and whether the market has really bottomed outWhich modalities and parts of the market feel resilient, and which are still strugglingHow FDA leadership changes are (and aren't) showing up in day-to-day workThe shift toward written-only FDA interactions and what that means for sponsor–agency relationshipsWhether regulators are prioritising speed or risk, and how that tension plays outWhere AI and digital tools are genuinely adding value today, versus where there's still a lot of noiseHow Quality has evolved from “policing” to partnership over the last 20 yearsWhy pragmatic, phase-appropriate Quality systems matter more than perfectionBurnout in senior Quality leaders and the risk of doing too much with too few peopleWhat separates Quality leaders who are listened to from those who are merely toleratedWhat the strongest Quality teams will be doing differently by the end of 2026Ed and Jon bring a huge amount of perspective, humility, and real-world insight to this discussion. This is a conversation for anyone leading Quality through uncertainty and trying to balance patient safety, speed, and sustainability.Hope everyone enjoys the show!

This week on Let's Talk Quality, we're joined by Elisabeth Hutchins, Senior Director of Quality at Upstream Bio, for a conversation focused entirely on one theme:How quality professionals make the transition from tactical execution to strategic leadership.In this episode, Elisabeth shares:What changes as a company enters Phase 2 and Phase 3The moment she realised she needed to stop firefighting and start planningHow she built the quality team around her to enable strategic thinkingThe soft skills that shape strong future QA leadersHow to balance urgent deliverables with long-term quality strategyWhy confidence is essential before others trust you as a strategic partnerElisabeth brings an honest and practical perspective that will resonate with managers and directors looking to step into bigger leadership roles.A highly insightful discussion for anyone looking to evolve into a strategic quality leader.

This week, Hemish is joined by Ashley Preston, SVP of Regulatory, Quality and Medical Writing at Blossom Hill Therapeutics, for a conversation about what it really takes to win hearts and minds early in quality leadership.Ashley took an unconventional path into QA, stepping into his first Quality leadership role after a long career in Regulatory Affairs.Because of that, he's had to lead through something far more important than technical depth: communication, trust, and people.In the episode, Ashley shares:Why he moved from Regulatory into Quality leadershipHow to build trust quickly when you're new to QAHow leaders can empower technical experts and still influence effectivelyPractical ways to build quality systems and culture in a small biotechWhy communication, self-awareness and soft skills matter more than everHow quality can earn a stronger, more strategic voice at the executive tableAshley's perspective is grounded, pragmatic, and incredibly relevant for leaders in emerging and clinical-stage biotech.#QualityLeadership #Biotech #RegulatoryAffairs #QualityCulture #LetsTalkQuality

From Greenfield to GMP.In today's episode, Hemish is joined by Kyle Powell, Head of Quality at Ratio Therapeutics.Kyle is a great example of the next generation of quality leaders who are building from the ground up - combining technical depth with a modern, empathetic approach to leadership.Kyle's career is an impressive story of growth, moving from regulatory consulting into radiopharmaceuticals, helping to stand up new facilities, and now leading the full quality build-out for Ratio's 65,000 sq ft Greenfield site in Salt Lake City. He talks about the following:How Kyle transitioned from regulatory strategy into quality leadershipWhat it takes to scale a quality system in radiopharma from zero to commercial readinessMoving from tactical work to strategic thinking as a leaderBuilding credibility and influence as a young quality leaderThe importance of empathy and communication in leading teamsHow to justify resources and headcount in a startup environmentCreating a digital-first, paperless quality function from day oneLessons from managing culture and mindset through growthThe softer skills that separate effective leaders from technical expertsAdvice for early-career professionals aiming to step into leadership rolesKyle is an ambitious and thoughtful leader - pragmatic, forward-thinking, and people-first.Thank you, Kyle, for sharing your incredible journey.Hope everyone enjoys the show!

In today's episode, Hemish was joined by Andrew Jones, former VP, Commercial Quality at Iovance Biotherapeutics.

Andrew is one of the few quality leaders who has actually built a cell therapy site from construction through to BLA submission, FDA inspection and final approval – all while growing and upskilling a team who were doing it for the first time.

Andrew's career spans 30+ years across biopharma, biotech, cell and gene and commercial launches. He's very intentional about principles - listen first, build trust, don't lie in front of an inspector - and he's done this in high-pressure, time-sensitive environments where approval is the company's lifeline.

He talks about the following:
• Moving from validation into site QA at a CDMO and how that set the foundation for future inspection work.• Lessons from Andrew's early BLA work at J&J and negotiating specs with R&D and FDA.• The reality of building a cell therapy facility during the pandemic and getting it inspection ready.• Why small and mid-sized biotechs underestimate the time vs patience problem in inspection readiness.• How to break inspection readiness into risk-based subcomponents instead of ‘boiling the ocean'.• The core inspection principles Andrew teaches his teams (listen first, build trust, never lie).• How to train a team that has never sat in front of an FDA investigator before.• The mindset shift from clinical to commercial in cell therapy – and why turnaround time becomes everything.• Leading at a steady temperature through BLA, inspections and approval.• Creating a culture where people feel safe to speak up, challenge and improve systems.Andrew is a calm, values-led quality leader who knows how to get therapies over the line without losing the team in the process.

Thank you Andrew for sharing your incredible journey.

Hope everyone enjoys the show!

In today's episode, Hemish was joined by Theresa Donegan, VP of Quality at Climb Bio.Theresa has spent the last few years helping biotech startups build quality from the ground up - often as a team of one. With 30 years' experience across every GxP environment, she brings a rare perspective on what it takes to move from large pharma structure to biotech agility, while still protecting compliance and patient safety.Theresa's career began in the QC lab before moving through GLP, GCP, and GMP roles in large and small companies, CROs, and now Climb Bio. Her path is a masterclass in adaptability, and in today's startup environment, her insights couldn't be more relevant.She talks about the following:• How Theresa's career evolved from QC lab work to VP of Quality leadership• The mindset shift from big pharma to biotech startups• What the first 30/60/90 days look like when you're building quality from scratch• How to balance pragmatism, speed, and compliance in early-stage biotech• How to use consultants effectively• The right time to bring in permanent quality leadership • What “good” looks like in an early-stage quality system• How to align leadership teams and departments when everything is moving fast• How to spot red and green flags when joining a startup• The key soft skills quality professionals must build early in their careers• How to prioritise your first three hires when you finally have budgetTheresa is an incredibly grounded and thoughtful leader, combining technical depth with an empathetic leadership style that every quality professional can learn from.Thank you Theresa for sharing your incredible journey.Hope everyone enjoys the show!

From £9,000-a-year QC analyst to global quality leader - Iain Rusling's story is a masterclass in soft‑skills, grit and making quality a strategic enabler.In today's episode, Hemish was joined by Iain Rusling, a global Quality & Operations leader and former Chief Quality Officer.Iain's journey - from QC benches in the UK to leading international, matrixed teams in Europe, captures the mindset, communication, and cross‑functional collaboration required to turn quality into a competitive advantage.Iain began in QC at small biotechs, built facilities and quality systems, moved through technology transfer and inspections, and later led global/EMEA functions from Munich. Along the way he faced setbacks, loss, consulting chapters, and major inflection points - all of which shaped a people‑centered leadership style that keeps him on the shop floor, not behind a desk.He talks about the following:Starting in QC on £9,000 a year and the mindset that accelerated his careerBuilding an oligonucleotide facility from scratch and what it taught him about influence without authorityMoving from site roles to global, matrixed leadership - how to earn trust across borders and culturesInspections and licenses (FDA/MHRA) as leadership pressure testsWhy quality must be represented in the boardroom - and how to make the caseTurning ‘quality as a cost' into ‘quality as continuity of revenue'Practical ways quality leaders can humanise their function: walk the floors, speak operations, build relationshipsInterview advice for QA leaders: questions to uncover culture, investment and phase‑appropriate systemsClinical → Commercial transitions: where companies get stuck and how advisory/fractional quality leaders helpAI realism: useful for trends and signals, but it can't replace human judgment on the shop floorIain is a thoughtful, pragmatic leader who combines technical depth with empathy, candour and a relentless focus on relationships.Thank you Iain for sharing your incredible journey.Hope everyone enjoys the show!

AI is here - and it's already changing the way we think about compliance, quality, and productivity in biotech.In today's episode Hemish was joined by Subbu Viswanathan, Head of Compliance at DashBio.Subbu because is one of the few quality leaders who has been building and integrating AI into quality systems for over a decade – long before it was mainstream. And he's now leading quality and compliance at a tech-driven CRO, where speed and automation are core to the model.Subbu's journey spans shop floor experience, software development, cloud QMS implementation, startup failures, AI audit tools, and now redefining what a modern bioanalytical CRO can be.He talks about the following:• What quality looks like when you build a company from scratch with AI and automation at the core.• How to move fast without breaking compliance.• What GLP and GCP readiness really involves in a fast-paced environment.• How to use LLMs and automation to handle audit questionnaires and generate CAPAs.• Why most GenAI pilots are failing in biotech.• How to think clearly about the noise vs. signal when it comes to AI tools.• Why quality leaders need to be AI-literate to stay relevant.• The slow death of traditional entry-level QA jobs – and what might replace them.• Why AI won't take your job – but someone using AI better than you will.• What a good quality mindset looks like in the age of digital transformationSubbu is a brilliant thinker who brings clarity, experience, and grounded insight to an often confusing topic.Thank you Subbu for sharing your incredible journey.Hope everyone enjoys the show!

In this episode, Hemish was joined by Karin von Hodenberg, VP of Quality at Monte Rosa Therapeutics.Karin has repeatedly built quality systems from the ground up across med device and biotech, and she translates that experience into practical, phase-appropriate guidance for early teams.Karin's journey is anything but typical: a business background, supply chain and Lean Six Sigma Black Belt training led her into quality at GE Healthcare and Philips, before moving into biotech with bluebird bio during rapid growth. She's since led in several startups and now at Monte Rosa, where she's implemented validated systems early and embedded a genuine culture of quality across GxP.She talks about the following:Why a non-traditional path (business → supply chain → Six Sigma) can be a superpower in Quality.From paper to validated eQMS: how bluebird bio migrated training & documents and why they verified 100% of records.Trigger points for moving beyond paper: signs you're outgrowing a doc control room and how to stand up DMS/LMS/LIMS early.Phase-appropriate, risk-based thinking: using data, science and regulations - without becoming a blocker.Making quality ‘cool': education, storytelling, and visible sponsorship from ELT.Leading without fear: replacing “inspection readiness day” with “inspection readiness every day.”Critical thinking over checkbox compliance: hiring, interview questions, and building the muscle across teams.Working with functional heads: cadence of 1:1s, being a partner (not a gate), and influencing through solutions.Roadmaps that breathe: Karin's 3‑year plan, quarterly outcomes, and how transparency sustains engagement in uncertainty.AI pragmatism in quality: where note-taking and drafting help now - and where human judgment still rules.Karin is a thoughtful, pragmatic Quality leader who balances compliance with business value - bringing people with her as she builds systems that last.Thank you Karin for sharing your incredible journey.Hope everyone enjoys the show!

Creating order from chaos: how a VP of Quality builds trust, leads through constraints, and keeps teams focused on patients.In today's episode Hemish was joined by Sep Naraghi, Vice President of Quality & Regulatory Affairs at Cellularity Inc.Sep has led quality in both Big Pharma and startups and has a practical, people-first approach to building trust, making trade-offs, and delivering under resource constraints.Sep's journey is anything but linear: from QC in generics to supplier quality at Boehringer Ingelheim, to leading quality and regulatory in a startup. His leadership philosophy is anchored in two values—trust and order—and he's candid about how feedback early in his career reshaped how he manages one-to-ones, builds transparency, and partners across the business.We talk about the following:Early path: QC in generics to supplier quality at Boehringer Ingelheim and an accelerated step into leadership.The two values that guide him—trust and order—and how childhood experiences shaped them.What changed in the industry: from “quality as police” to quality embedded early and driving value.Practical ways he learned softer skills: asking more questions, reading the room, and focusing on people in 1:1s.Big Pharma vs startup: resource constraints, creative problem-solving, and prioritising the ‘must-haves'.Keeping culture strong under pressure: transparency, bi-weekly team forums, and cross-functional partnership.Managing up and across: using a ‘ladder of inference,' lunch-and-learns, and making the logic visible.Hiring and fit for startups: flexibility, curiosity, blunt-but-respectful dialogue, and support from your boss.Creating order from chaos: bringing structure to reach IND/BLA milestones without losing speed.Advice for aspiring leaders: lean into discomfort; empathy over ego; and build trust before you need it.Sep Naraghi is a thoughtful, values-led leader who turns ambiguity into execution, champions transparency, and builds teams that do the right thing for patients and the business.Thank you Sep for sharing your incredible journey.Hope everyone enjoys the show!

From rock guitarist to VP of Corporate Quality, Tony shows how principles, clear choices, and modern tools like AI can level-up how quality leaders think and operate.In today's episode, Hemish was joined by Tony Jones, Vice President, Corporate Quality at Syneos Health.Tony's path is anything but typical: NHS clinical biochemistry, clinical pharmacokinetics at Beecham/GSK, a move to France, and then landing, almost by accident, in QA leadership in New Jersey. He went deep on GLP and data principles, published prize-winning work, and has since focused on education, strategy, and the creative application of regulation to help teams do their best work.He talks about the following:The unconventional route from aspiring guitarist to Director of QA and beyond.What clinical labs taught him about data and why that matters in pharma/biotech quality.GLP as a canvas: distilling regulation into simple, durable principles.Data integrity beyond acronyms: accuracy, completeness, consistency and study reconstruction.Why strategy is a set of choices (Roger Martin) and leaving room for emergence (Mintzberg).Decision-making lenses leaders can actually use: broaden options, avoid false binaries, and think before acting.Critical thinking by design: two questions - “What's going on?” and “What should I do about it?”.AI in the quality toolkit: daily use cases, custom agents, and why bottom‑up experimentation matters.Training and culture: shifting from static courses to on-demand, problem-first learning.Career advice: learn continuously, evidence change, take morning walks, make space for reflection.Tony is a thoughtful, principles‑driven quality leader who blends scientific depth with practical strategy and a genuine passion for learning and teaching.Thank you Tony for sharing your incredible journey.Hope everyone enjoys the show!

In this week's episode, Hemish was joined by Scott Pherson, Senior Director of Quality Assurance at AS2 Bio.Scott has made the transition from big pharma to startup biotech three times. And now, he's building quality from scratch at a company that hasn't even dosed a patient yet.Scott has nearly 20 years' experience across QC, operations, and quality leadership, having worked at Biogen, Shire, AvroBio and more. Now, as the first quality hire at AS2 Bio, he's building systems, shaping culture, qualifying vendors, and laying the groundwork for clinical success.He talks about the following:

In today's episode, we are joined by Stephanie Martin, Director of QA and Product Quality Lead at Adaptimmune.Stephanie's journey into quality leadership is anything but traditional. She started out as a nuclear engineer at a shipyard before pivoting into biotech and building a career in quality. What stands out is how she has faced bias around her age and appearance head-on, and still accelerated into leadership roles by focusing on EQ, credibility, and consistent performance.Stephanie's story is a brilliant case study in how you can lead without waiting to be told you're ready.We talk about the following:

In today's episode, I was joined by Megan Callan, Vice President of Quality at Abeona Therapeutics.I really wanted to speak to Megan because her last few years at Abeona have been a masterclass in building a quality organisation that can handle the demands of commercial manufacturing - all while driving a digital transformation and keeping a patient-first mindset.Megan has a unique career journey, moving across different industries and company sizes, and in this conversation, she opens up about how she's navigated the shift from tactical to strategic leadership, what it takes to scale a quality team rapidly, and how AI is already influencing the role of QA.We talk about the following:

In today's episode I was joined by Nolan Polson, Vice President of Quality Assurance and Product Quality at Iovance Biotherapeutics.I really wanted to speak to Nolan because he's one of the few leaders who's built quality teams at every stage – from biologics at Amgen to radiopharma at Janssen, to launching two first-in-class cell therapies at Juno/Celgene/BMS.Nolan's career path is a great example of what it looks like to carry foundational quality principles into fast-paced, high-growth settings. He talks about his early scientific passion, how he transitioned from R&D to Quality Ops, and the leadership mindset required to scale from clinical to commercial.We talk about the following:How Nolan's scientific roots in chemistry shaped his quality mindsetTransitioning from R&D into Quality Ops and building speed with structureWhat Big Pharma taught him about good science, mature systems, and agency collaborationScaling product quality teams from 2 to 45 during two cell therapy launchesBuilding empowered leadership teams and the traits he looks for when hiringHow AI can help quality teams move toward review-by-exception and proactive oversightThe difference between biologics and cell therapy mindsets in a commercial settingCreating a culture of continuous learning and succession planningLessons from moving across Amgen, J&J, GSK, BMS, and IovanceWhy autologous cell therapy still holds massive curative potentialNolan is a thoughtful, experienced quality leader who blends deep scientific expertise with a calm, strategic leadership approach.Thank you Nolan for sharing your incredible journey.Hope everyone enjoys the show!

In today's episode I was joined by Ashley Argiras, VP of Quality at Recursion.I really wanted to speak to Ashley because she's helping redefine what quality leadership looks like in a tech-enabled, platform biotech - and she's doing it by shifting how people think, not just how they work.Ashley's journey into science started in high school - not in a lab, but making ice cream during chemistry class. That moment sparked a lifelong curiosity that took her to Indiana University, and eventually into clinical research. She began her career as a CRA at Eli Lilly, where she visited trial sites and became the first line of quality, working hands-on with investigators to ensure patient safety and protocol integrity.That experience gave her a real-world understanding of what quality means at the ground level, and it's shaped the way she leads today: rooted in purpose, driven by questions, and always looking for better ways to serve patients.We talk about the following:

In today's episode I was joined by Maja Pedersen, Chief Technology Officer at Fujifilm Diosynth Biotechnologies.I really wanted to speak to Maja because she leads quality and IT across six global sites, and has a brilliant perspective on how quality leadership is evolving - especially when it comes to people, systems and technology.She has a calm, clear way of thinking, and we covered everything from shifting your mindset as a leader, to integrating AI in a global quality function, to maintaining personal resilience and clarity.We talk about the following:

From engineering student to SVP of Quality - Carolina shares how curiosity, resilience, and mentorship shaped her journey.In today's episode I was joined by Carolina Valoyes, Senior Vice President of Quality and Compliance at BioNova Scientific.I really wanted to speak to Carolina because her story is one of bold decisions, genuine self-awareness, and a leadership style grounded in service, not ego.She started out as an engineer in Colombia, came to the US without speaking a word of English, and moved her way into biotech leadership by staying curious, staying humble, and always aiming to contribute. Her reflections on mentorship, emotional resilience, and coaching-based leadership were powerful.

In this episode of Let's Talk Quality, Hemish speaks with Jose Caraballo, a biotech leader with over 30 years of experience in process engineering, manufacturing science, and quality leadership.Jose started his career in process engineering, optimizing yields and scaling up production. Over time, he made a deliberate shift into quality leadership, recognizing that understanding the external side of the business - suppliers, regulators, and customers, was just as important as technical expertise.Now, as a VP of Quality at Kite Pharma, a leader in cell therapy manufacturing, Jose is deeply involved in shaping the future of quality in biotech and remains passionate about driving innovation and leadership in the biotech space. In this conversation we cover:✅ The shift from compliance-focused quality to strategic quality leadership✅ Why quality is a company-wide responsibility, not just a QA function✅ How moving from technical roles to quality leadership can accelerate career growth✅ The importance of curiosity and adaptability in biotech✅ How CGT is changing expectations for speed, risk management, and patient impact✅ The role of automation and AI in quality systems✅ Lessons from moving into senior leadership and managing teams effectively✅ What biotech companies need to focus on to embed quality culture at every levelJose's career journey is a great example of how technical expertise, business strategy, and leadership all come together to drive impact in biotech.

This week on Let's Talk Quality, we sat down with Andrea Karpinecz, VP of Quality Control at Iovance Biotherapeutics, to discuss what it takes to build a successful QC career, scale teams for commercialization, and thrive in a high-pressure environment.Andrea has been in cell therapy for 16+ years, playing a pivotal role in bringing multiple therapies to market - including some of the first commercially approved CAR-T and TIL therapies. She's seen firsthand what it takes to move from the bench to executive leadership and shares key insights for QC professionals who want to grow their careers but aren't sure where to start.

In today's episode, I was joined by Biana Torres, Senior Director of Quality Assurance at Encoded Therapeutics.I really wanted to speak to Biana because she has built a strong leadership career in quality, moving through both big pharma and small biotech. She's now leading in the dynamic world of cell and gene therapy, where quality and adaptability are critical.Biana started out aiming to be a doctor, pivoted into biotech by accident, and has since built a career leading quality teams through acquisitions, evolving regulations, and high-impact projects that put patients first.We talk about the following:

In today's episode, I was joined by Shane Ernst, Vice President of Quality at Empower Pharmacy.I really wanted to speak to Shane because he has built an incredible career in quality leadership despite being an introvert - a trait many in the industry can relate to. His journey from analytical chemist to VP is full of valuable insights on leadership, career progression, and navigating high-stakes regulatory challenges.We talk about the following:

In this episode of Let's Talk Quality, Hemish sat down with Rob Dallimore, Head of Quality at Wugen, to discuss his inspiring 25+ year journey in quality assurance and leadership. Rob's experience spans small molecules, biologics, and cell therapy, giving him unique insights into what it takes to succeed across different modalities.Rob shared invaluable lessons from his career, including the mindset required to pivot into new areas of expertise, how to build resilient teams, and his experience leading quality systems for commercialization at both start-ups and Big Pharma. Key highlights include:

In today's episode, I'm joined by Jon Voss, one of the all-time quality greats!I've been working with Jon over the past 18 months. I'd describe him as a true gent - very humble, incredibly funny with a dry sense of humour, and someone who is so passionate about this industry.Unsurprisingly he has developed some of the leaders I've interviewed on this show!What shines through in this episode is the balance between pragmatism and patient safety.We talk about the following: The evolution of quality from compliance-driven to patient-first approachesWhy and how moving around different careers benefited Jon's career.Lessons learned from leading quality teams through commercialization milestones.Phase appropriate quality and how to actually implement systems accordingly.Keeping the end goal in mind whilst maintaining patient safety.Utilising Technology and AI to speed up drug developmentHow to transition into commercial quality.Why learning how to speak in public will improve your career opportunities. Jon is so passionate about helping and inspiring the next generation of leaders. His stories and advice offer invaluable insights for anyone working in or aspiring to quality leadership roles.Thank you, Jon, for sharing your incredible journey, wisdom and lessons you've learnt.Whatever level you are in your career, there is something to be learned from in this episode.Hope everyone enjoys the show!

On this week's episode of Let's Talk Quality: The Podcast

On this week's episode of Let's Talk Quality: The Podcast

On this week's episode of Let's Talk Quality: The Podcast

In this episode, I had the privilege of speaking with Matthew Wheeler, Vice President of Quality and Clinical Operations at Precision BioSciences.Matthew's journey is nothing short of inspiring. From starting his career in food manufacturing at Kellogg's to building a career in biotech, his story is one of resilience, adaptability, and leadership.In the past year, Matt was diagnosed with not one, but three rare diseases, including GPA vasculitis and IgA nephropathy.Despite these challenges, he continues to lead with strength, empathy, and gratitude.We covered a lot of ground in this conversation, including:Transitioning from food manufacturing into biotech and navigating the early challenges of his career.The breadth of experience gained that shaped his expertise.The importance of mentors and leadership in personal and professional growth.Building a quality function at Precision BioSciences and integrating quality into R&D operations.His personal health challenges and how they've influenced his outlook on life and leadership.His commitment to service, gratitude, and family as guiding principles in his life.Matthew's candidness about his recent health challenges and their impact on his perspective was incredibly moving.Thank you, Matt, for sharing your story with such honesty and vulnerability. It's leaders like you who remind us of the impact that Life Science professionals have on patients' lives.I hope you enjoy hearing Matt's story as much as I did—it's one you won't forget!

In this conversation, Lauren Smith, Chief Quality Officer at OrcaBio, shares her journey into the field of quality assurance, discussing her early career, leadership experiences, and the importance of connecting work to patient outcomes. She emphasizes the challenges and rewards of working in quality assurance, the significance of practical quality, and the need for purpose-driven leadership. Lauren also highlights the importance of employee development, self-awareness, and the impact of pivotal moments in her career.Takeaways:Lauren fell into quality assurance rather than choosing it intentionally.Her early experiences in environmental monitoring were invaluable for her career.Quality roles allow for direct impact on patient safety and product quality.The quality assurance field is constantly evolving and challenging.Lauren values authenticity, integrity, and kindness in her leadership.She emphasizes the importance of connecting work to a greater purpose.Practical quality and team dynamics are crucial for success in quality assurance.Employee development should be tailored to individual goals and needs.Self-awareness is key to effective leadership and personal growth.Lauren believes in leaving a quiet legacy through her interactions with others.For anyone looking to learn about how to hire great people, build a purpose driven culture, and develop their people, this is a great episode to listen to!Thank you Lauren for joining us!Hope everyone enjoys the show!

Sean Smith, Vice President and Head of Quality at KSQ Therapeutics, shares his journey from working in big biotech to transitioning into small biotech and the challenges and opportunities that come with it. He emphasizes the importance of being willing to challenge the status quo, having an openness to learning, and practicing empathy as a quality leader. Smith also discusses the need for quality to be seen as an asset and the importance of building empowered and diverse teams. He encourages aspiring quality leaders to become experts in one or two areas to differentiate themselves.Takeaways: Be willing to challenge the status quo and ask why things are done a certain way.Have an openness to learning and constantly strive to improve.Practice empathy and build relationships to create a positive quality culture.View quality as an asset and strive to integrate it early in the product realization process.Differentiate yourself as a quality leader by becoming an expert in one or two areas.

In today's episode, I'm joined by Andrea Goddard, former Chief Quality Officer at Genentech. Andrea shares her career journey and insights into quality leadership. She started in biotech manufacturing and transitioned into quality after a conversation with her boss! Andrea emphasizes the importance of building strong relationships between quality and other departments within an organization. She discusses the challenges and rewards of working in a global role, including managing different time zones and cultures. We cover:Building strong relationships between quality and other departments.Managing different time zones and cultures.The importance of respect, authenticity, and work ethic.Using data to make informed choices.Putting yourself outside of your comfort zone.A huge thank you to Andrea for joining us on the show and for giving us her time. She's had an incredible 30-year career with Genentech/Roche, starting in 1995, and positively impacting so many lives along the way. Hope you enjoy the show!

In today's episode, we're joined by Gary Barrera, Senior Vice President of Quality and Regulatory at Vera Therapeutics.Gary shares that his love for reading and learning, as well as his curiosity about how things work, led him to pursue a career in science. He started in manufacturing and eventually moved into quality, where he discovered his passion for ensuring the reliability and safety of products. We talk about the benefits of gaining exposure to different areas of an organization and how that has helped Gary become the leader he is today!We discuss the following:The evolution of quality in the industry.The importance of a strong quality culture .The advancements in data integrity. Addressing fraud in the industry.Importance of crisis management.Learning what & how your operational partners do.Collaborating effectively.Chapters00:00 Introduction and Podcast Inspiration02:56 Getting into Science and Transitioning into Quality07:12 The Role of Change Control in Gary's Quality Journey09:34 The Importance of Quality Culture and Data Integrity24:37 Pivotal Moments in Gary's Career Journey35:40 Important Values and Advice for Future Quality LeadersA huge thank you to Gary for joining us!Hope you enjoy the show!

In today's episode I was joined by Andrew Cieri, Senior Director of Quality for Regeneron's newly acquired cell therapy unit. Regeneron are launching a new cell therapy unit after the acquisition of the pipeline and commercialisation rights to 2seventy products and Andrew has been tasked with launching this unit! I wanted to talk with Andrew to learn about his journey and how he's gone developing himself - both as a quality professional and leader.Chapters00:00 Introduction and Background03:58 Early Interest in Science and Technology07:56 Transition from Manufacturing to Quality11:14 Transition into Leadership in Quality22:58 Impact on Product Quality and Reflections28:03 Current Focus and Future Plans34:12 Values for Success in Quality Assurance36:39 Leaving a Legacy and Advice for Future Leaders39:23 Conclusion and Contact InformationThroughout his career, Andrew has been proactive, from transitioning into quality from manufacturing to going back to school to do a Masters in Engineering Management to develop his leadership skills. He's shown self-awareness throughout his career and still to this day is always looking to improve himself as a leader.Thank you for joining us, Andrew, and looking forward to seeing all the amazing work you and your team do for patients in the future.

In today's episode I'm joined by Laura Malagon, VP Quality and Regulatory at Grand River Aseptic Manufacturing.Laurie (as she is known as to those close to her) recently relocated from Miami to Michigan to lead the quality organisation at GRAM. She's had a fantastic journey in quality, starting her career washing glass-wear in a laboratory! We talk about the following:Relocating from Miami to Michigan this year for a new VP role.Laurie's journey into science and quality. Working with different modalities, therapeutics and organizations.Laurie's love for quality and why she still has a passion for the industry.How the industry has evolved since she started.Communicating and leading cross-functionally.Moving from established organization to start-up. Laurie's hope for the futureAdvice for quality professionalsThe one person who inspired her the most.Laurie's story should give inspiration to a lot of people in the early stages of their quality career that would like to progress into a Head of Quality one day.She is kind, generous and incredibly passionate about leadership, quality and bringing safer medicines to patients. She's shown resilience throughout her career which has allowed her to widen her remit and grow her career. Her ambition to further her career shines throughout this conversation.Thank you Laurie for sharing your incredible journey from washing glass-wear all of those years ago to where you are now! Excited to see you continue to impact lives in your career.Hope everyone enjoys the show!

In today's episode I was joined by James Myers, VP Quality at Spyre Therapeutics.I wanted to speak with James about his journey, starting in GCP focussed roles and learn how he transitioned into all encompassing GxP position. As a result James has gained exposure across GCP and GMP and developed himself as a true GxP quality professional. We discuss the following:Transitioning from GCP to GMP.Industry Trends.Gaining GMP Experience.Advancing to VP from director.Building a Team and Pilot Plant.Collaboration with Stakeholders.Gaining Organizational Buy-In.Importance of Listening.Strategic Thinking.'Jim' is a great leader and most importantly a genuinely nice human being that has impacted people throughout his career in pharma and biotech. He is a credit to the industry and I'm sure his journey will inspire others to follow in his footsteps!Thank you Jim for sharing your journey with us!Hope everyone enjoys the show.

Today I'm joined by Kelly O'Hare, current Vice President, Head of Quality at enGene, an innovative biotech developing a very exciting non-viral gene therapy focussed on bladder cancer.Kelly shares her journey in quality, discussing her transition from a technical writer to a quality leader. We talk about the importance of quality leaders being able to articulate the value of quality to their organizations. Her insights provide valuable lessons for aspiring quality professionals and leaders.TakeawaysKelly's journey into quality began unexpectedly from a background in broadcast journalism.Mentorship played a crucial role in shaping her leadership philosophy.Building confidence in decision-making is essential for quality leaders.Quality should be defined in terms of efficiency and safety.User feedback is vital for successful quality system implementation.Quality management systems should be tailored to the organization's needs.Evolving perceptions of quality have led to greater appreciation from leadership.Inspiring passion for quality involves recognizing individual interests.Legacy is defined by the success of those you mentor and support.Future quality leaders should be confident yet flexible in their decision-making.Chapters00:00 Introduction to Quality and Career Journey02:55 Transitioning from Science to Quality Leadership06:03 Building Confidence in Quality Decisions08:52 Defining and Articulating Quality11:59 The Importance of Quality Management Systems14:58 User Feedback and Quality System Implementation17:59 Evolving Perceptions of Quality in Organizations20:55 Inspiring Passion for Quality in Teams23:50 Legacy and Mentorship in Quality Leadership27:02 Final Thoughts and Advice for Future LeadersThis is a great conversation about the significance of defining and articulating quality to your organisation and the benefits this brings. Thank you Kelly for joining us on the show!