Let's Talk Quality

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: 🎙️ Moving from large pharma to lean biotech 🎙️ How to stand out in startup interviews 🎙️ Why AS2Bio hired quality *before* going to clinic 🎙️ How to prioritise when you’re the first quality hire 🎙️ What founders get wrong about consultants 🎙️ Cultural priorities when embedding quality early 🎙️ Building brand value to attract talent in Boston 🎙️ The mindset needed to thrive in ambiguity 🎙️ His player-coach leadership style 🎙️ His advice to aspiring quality leadersScott is a thoughtful, experienced and humble leader - someone who blends strategy, scientific rigor, and people-first leadership to help biotech companies move fast without cutting corners.Thank you Scott 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 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:🎙️ Megan’s early career moves and how she found her way into quality🎙️ Leading Abeona’s scale-up from early clinical to commercial readiness🎙️ Growing a QA team from 5 to 60+ people in a short timeframe🎙️ The shift in mindset from tactical execution to strategic leadership🎙️ Lessons learned from a major digital transformation project🎙️ How to align quality with business objectives and patient needs🎙️ Building resilience and navigating change at pace🎙️ The role AI and IT now play in quality operations🎙️ Advice for aspiring quality leaders who want to step into senior rolesMegan is a thoughtful and forward-thinking quality leader whose approach blends business acumen, strategic foresight, and a deep commitment to patient outcomes.Thank you, Megan, 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!

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:🎙️ How quality supports speed in a platform biotech🎙️ Ashley’s early career in clinical trials and where it all began🎙️ Teaching teams to ask better questions, not follow checklists🎙️ What “inspection ready” really means in a modern organisation🎙️ Why judgment and empowerment are better than policy and policing🎙️ How Ashley thinks about org structure during scale-up🎙️ Leading with listening (and learning to talk less as a VP)🎙️ Avoiding the bottleneck trap as a quality leader🎙️ Building a safe space for decisions - even if they’re wrong🎙️ Lessons in growing from tactical QA to strategic leadershipAshley is a sharp, thoughtful leader proving that real quality leadership starts with having the right mindset.Thank you, Ashley, for sharing your incredible journey.Hope everyone enjoys the show!

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:🎙️ Making the leap from tactical to strategic thinking🎙️ Leading teams across multiple countries, time zones and cultures🎙️ Building trust in new teams and showing up authentically🎙️ Balancing the people side of quality with system thinking🎙️ How to think and lead when you're not the technical expert🎙️ Staying grounded and maintaining well-being while leading at scale🎙️ Where quality and IT need to work hand in hand🎙️ Why quality leaders must develop digital and data fluency🎙️ How AI will reshape the future of quality in biotech🎙️ Advice for future leaders stepping into global rolesMaja is a thoughtful, strategic leader who balances big-picture thinking with deep care for people and culture.You can watch on LinkedIn Live at 8am EST today or listen via Apple or Spotify.Thank you Maja for sharing your incredible journey.Hope everyone enjoys the show!

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.🎙️ We talk about the following:How she went from Colombia to the US without knowing English and starting her career in Biotech at Bayer Her first role supervising a team 15 years her seniorWhat an early inspection mistake taught her about resilienceHer transition from manufacturing into qualityThe guiding principles that drive her career decisionsWhether curiosity can be taught - and how to coach itThe importance of painting a positive vision, not using fearAdvice for navigating “politics” at VP levelWhat she looks for when hiring leaders Her advice to aspiring quality leadersCarolina is an inspiring leader who brings humility, sharp thinking, and deep care for people into every part of her work.Thank you, Carolina, for sharing your incredible journey.Hope everyone enjoys the show!

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 this episode, we cover:✔ How to transition from a technical QC role to leadership ✔ Lessons from leading QC for two commercialized cell therapies✔ The biggest challenges in preparing for commercialization and how to solve them✔ Why hiring for mindset is just as critical as technical expertise in QC ✔ How to build resilience as a leader in a high-pressure, fast-moving environment✔ The future of cell therapy and what it means for QC careersFor QC professionals wondering what’s next in their careers, Andrea breaks down why moving into leadership doesn’t mean leaving QC. There’s a clear path forward—whether you want to become a VP, Director, SME, or eventually step into executive roles.🔹 This episode is a must-watch for QC leaders preparing for the commercialization of an ATMP.

🚀 The first-ever returning guest on the podcast!In this episode, Hemish sat down with Brian Nunnally, Enterprise Quality Control Head at CSL, to dive deep into one of the most important topics in career growth - mentorship.Brian’s career is a perfect example of how mentorship, strategic career moves, and leadership development can accelerate your path to the top. He shares his journey from QC scientist to leading an entire global Quality Control organization, and why having the right mentors at the right time made all the difference.💡 Key topics we cover:🔬 How Brian navigated multiple lateral career moves to break through to VP level📈 Why mentorship is crucial at every stage of your career (even for senior leaders!)🎯 How to find the right mentor and what questions to ask💡 Why focusing on strengths, rather than weaknesses, can drive faster career growth💬 How leaders can stay positive (without being fake)👥 The power of paying it forward - why senior leaders should invest in mentoring the next generation.📺 Watch the full episode today at 12pm EST on LinkedIn Live🎧 Listen on Apple & SpotifyIf you're a Quality professional who might be feeling stagnant in your career, break through plateaus, improve your mindset, or find the right mentor, this episode is for you. 

🎙️Would you move to a new country with no network, no guarantees - just a dream and two suitcases?That’s exactly what Katarina Bartle did.She left Slovakia, where she had built a strong academic foundation, moved to Germany for her PhD, and then took a huge risk, relocating to the U.S. for what was meant to be a short postdoc.27 years later, she’s still here - now a biotech quality leader who has shaped global teams and helped redefine how companies approach quality.In today’s episode of Let’s Talk Quality, Katarina shares:✅ The challenges of moving to a new country and building a career from scratch ✅ How she transitioned from scientist to compliance and quality leader ✅ The importance of having a strong voice in leadership discussions ✅ Why quality leaders need to think like business leaders, not just auditors ✅ Her biggest leadership lessons and career advice for aspiring VPsThis one is packed with career insights, resilience, and real leadership lessons—don’t miss it.

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:🎙️ Her unexpected entry into quality through a temp job at Baxter🎙️ The transition from big pharma to small biotech and what she learned from both🎙️ Why cell & gene therapy is different from traditional small molecule and biologics🎙️ How quality leadership has evolved from being "the police" to a business partner🎙️ The impact of working at Kite during a pivotal time for the industry🎙️ How she overcame the "no CGT experience, no interview" hiring barrier🎙️ The mindset shift needed to work in advanced therapies🎙️ The importance of coaching & mentorship in leadership development🎙️ Why future quality leaders need to think outside the boxBiana is a passionate leader who thrives in fast-moving biotech environments. She’s driven by curiosity, continuous learning, and a commitment to mentoring the next generation of quality leaders.Thank you, Biana, for sharing your incredible journey.Hope everyone enjoys the show!

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:🔹 How he accidentally fell into quality after starting in analytical chemistry🔹 The early career moment that forced him to step up despite his introverted nature🔹 Why quality leaders need to develop cross-functional business knowledge🔹 His biggest leadership challenge - building confidence as an introvert🔹 How he learned to manage his energy as a leader while staying authentic🔹 What it was like turning around a 1,300+ complaint backlog at a major pharma site🔹 Why trust with regulators is essential and how to build it🔹 The shift from tactical to strategic thinking when moving from Director to VP🔹 How he develops and mentors future leaders in quality🔹 His advice for aspiring VPs - getting out of your comfort zone is keyShane is a fantastic example of how leadership isn’t about personality type - it’s about mindset, adaptability, and growth. His story proves that introverts can thrive in senior leadership roles and have a huge impact on their teams and companies.Thank you, Shane, for sharing your incredible journey.Hope everyone enjoys the show! 🚀 

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:🎤 Rob’s transition from the UK to the US and stepping into leadership roles.🎤 The challenges of job hunting in a highly competitive biotech industry.🎤 Navigating the shift from small molecules to biologics and cell therapy.🎤 How to hire and train QA teams without specific modality experience.🎤 The importance of leading with empathy, resilience, and adaptability.🎤 Building compliant, efficient quality systems for commercial readiness.🎤 Lessons learned from late-stage clinical trial failures and bouncing back stronger.🎤 Wugen’s mission to license the first allogeneic CAR-T therapy in the US. Rob’s career demonstrates the power of stepping outside your comfort zone and taking on challenges to drive meaningful impact in the life sciences industry. Thank you, Rob, for such an insightful conversation. We’re looking forward to seeing Wugen’s exciting journey unfold.

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🎙️Hemish Ilangaratne is joined by Hanh Nguyen, Site Head of Quality at Minaris Regenerative Medicine, a global CDMO specializing in cell and gene therapies.Hanh’s career started in document control at Amgen, spending over a decade in Big Pharma, before taking a leap into smaller, fast-paced organizations. That move - stepping out of her comfort zone, was a pivotal moment that accelerated her growth and confidence as a leader.Hanh is a brilliant example of someone who’s balancing rapid career progression with deep self-awareness. In this episode, she opens up about: ✅ Overcoming imposter syndrome and trusting your experience.✅ How to adapt your leadership style to motivate and engage a new generation of talent.✅ The importance of prioritizing mental health - both for yourself and your team.✅ Creating strong relationships between sponsors and CDMOs to drive success. If you’re a quality leader (or aspiring to be one), this episode is packed with practical tips and insights on building high-performing, engaged teams while staying true to yourself.Hope you enjoy the show!

On this week's episode of Let's Talk Quality: The Podcast🎙️Hemish Ilangaratne is joined by Sang Yoon, VP of Quality Assurance at ImmunityBio, a cell and gene therapy company based in California.Sang’s story is truly inspiring. With 25+ years in biologics, medical devices, and healthcare, he’s been at the forefront of product launches, recalls, and scaling operations globally. But what stood out to me most was his approach to leadership:✅ Build a community first✅ Lead with trust, self-awareness, and adding value✅ Create a culture where people thrive, learn, and growSang shared so many practical tips for quality leaders, especially around shaping culture in the first 90 days of a role and developing your leadership style:Build relationships across all levels of the teamBe self-aware: your actions and words influence cultureFocus on developing learning organizationsAdd value to your people—find ways to help them thriveWe also talked about Sang’s experiences transitioning from sponsor companies to CDMOs and what really excites him about ImmunityBio’s journey.If you’re an aspiring leader, there’s so much to take from this conversation. Thank you, Sang, for sharing your insights! 🎙️

On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Swetha Krishnan, Executive Director and Head of Quality at Mural Oncology, a fast growing biotech in Waltham, Massachusetts.Here's what they discuss:How Swetha's upbringing shaped her career progression 🚀 Moving from India to the US to pursue a career in science 🧬 Why wearing so many hats early on improved her confidence 👏 Why you don't always need all of the answers 🗯️ Balancing technical expertise with emotional intelligence ✴️ Learning to be adaptable and removing biases ✔️ How to develop and build credibility as a leader🔥 If you’re an aspiring leader, this episode will help you understand some of the key traits and characteristics to focus on to reach your full potential as a people leader.Huge thank you to Swetha for joining us on the show!

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!