Let's Talk Quality

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.

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.

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.

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.

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 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, 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

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!

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!

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!

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 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:🎙️Starting her career in a shipyard as a nuclear engineer.🎙️Developing emotional intelligence in an industrial setting.🎙️Transitioning into biotech and discovering her passion for quality.🎙️Why a Director saw leadership potential in her before she did.🎙️How she learned to influence without direct authority.🎙️Overcoming bias around age, appearance, and experience.🎙️Building credibility and scaling her impact at TCR² and Adaptimmune.🎙️The mindset shift from tactical to strategic decision-making.🎙️Her approach to hiring and coaching future quality leaders.🎙️The advice she’d give to other young leaders looking to make their mark.Stephanie is a thoughtful, driven, and emotionally intelligent leader who’s helping shape the future of quality in cell and gene therapy.Thank you Stephanie for sharing your incredible journey.Hope everyone enjoys the show!

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!