Let's Talk Quality

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: 🎙️ 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!