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: 🎙️ 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! 🚀