“Let’s Talk Quality” is a podcast that seeks to shine a light on quality assurance, a profession that acts as the cornerstone for bringing safer medicine to patients. For life science companies to continue to develop life-saving medicines, a culture of good quality must be driven across the industry, whether that be an early phase gene therapy biotech or a global pharma organisation. This podcast aims to drive that mission forward through inviting industry leaders, experts, and visionaries to share their knowledge, experiences, and strategies for achieving quality excellence. Join us on a journey of discovery as we unravel the importance of quality and its profound impact on businesses and society. Get ready to engage in insightful discussions, gain valuable perspectives, and unlock the secrets to fostering a culture of quality in every aspect of life. Tune in and let’s embark on this exciting quality-driven adventure together.
Season Four is at its halfway point, so instead of a guest this week I’ve gone back over the conversations so far and pulled out the theme that came up most often. The quality leader whose main function is to say no is finished. This episode is four clips from Season Four guests on that theme, with my own thoughts in between. I also talk about why I think this matters for your career and not just for your working relationships, which comes from the other half of my week, placing quality leaders and hearing what hiring managers are actually asking for. Get in touch If you’re going through that step up at the moment, I’d be interested to hear about it. Find me on LinkedIn, or book a conversation here: https://calendly.com/h-ilangaratne/meeting-with-hemish-rx-group If there’s a topic you’d like covered on a future solo episode, send it over. Timestamps: (00:00) - Intro - Halfway Through Season Four (01:50) - The Old Reputation - Tim Mitchell (03:30) - Hemish's Take - Reputation vs. Reality (04:23) - Saying No Is the Easy Option - Kim Garko (05:51) - Hemish's Take - The Career Angle (07:21) - Translating Risk for the Business - Jamey Lindholm (10:02) - Hemish's Take - Practical Application (10:59) - Partnership Over Policing - Rex Ready (14:21) - Closing Thoughts - What This Means for Quality Leaders
Quality culture isn't built by SOPs. It's built in the small moments when a leader reinforces the right behaviour or lets the wrong one slide. Speaking the Language of the Business, with Jamey Lindholm. In today's episode I was joined by Jamey Lindholm, Vice President of Quality at R1 Therapeutics. I really wanted to speak to Jamey because she has led Quality through nearly every stage a career in this industry can throw at you: a first-in-class FDA approval at Seres Therapeutics, an acquisition by Merck KGaA at Springworks, and now building a Quality function completely from zero as R1's very first Quality hire. She has strong, hard-won views on how to get each of those right. Jamey's journey started almost by accident. She fell into a QC chemistry job at a small biotech straight out of university, got laid off a year later when the company ran out of funding, and then spent the next 20 years at Biogen, where she built the foundation of what she now calls "what good looks like" in Quality. From there she moved to Seres Therapeutics, where she led end to end Quality through the first FDA approval of a microbiome-derived oral therapy, then to Springworks through its acquisition by Merck KGaA, and now to R1 Therapeutics as its first Quality hire. What comes through across the whole conversation is a leader who has thought deeply about the difference between compliance and culture. Jamey is clear that Quality earns its seat at the leadership table not by enforcing SOPs, but by translating compliance into risk, into regulatory consequence, into business decisions that leadership teams actually understand. She is equally clear that the industry has a visibility problem. Almost nobody chooses Quality as a career at school, and she believes that is something the industry has an obligation to fix. We talk about the following: Why 20 years at a large pharma company can make the move into a startup harder, not easier The difference between managing Quality operations and being responsible for end-to-end Quality at a small company Why "quality risks are business risks" changes how a leadership team makes decisions What actually builds quality culture, and why it isn't SOPs The moment Seres received FDA approval for Vowst, and why it felt different from anything Jamey experienced at Biogen Why it's never too early to bring in a permanent Head of Quality, and what that decision signals about a company's culture Why Quality is invisible as a career choice to STEM students, and what the industry can do about it Jamey is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Jamey for sharing your incredible journey. Hope everyone enjoys the show. WHO THIS EPISODE IS FOR A Head of Quality or VP Quality building a function from scratch at a startup A big pharma quality professional considering a move into biotech A founder or CEO deciding when to bring in a permanent Head of Quality A quality manager trying to build genuine culture, not just documentation A STEM student or early-career scientist who has never considered Quality as a career path Timestamps: (00:00) Introduction to Jamey Lindholm and Her Career Journey (02:41) Transitioning from Big Pharma to Startups (05:14) Navigating Quality in Complex Environments (07:38) The Role of Quality in Business Strategy (10:16) Building a Quality Culture in Startups (13:14) Hiring for Quality in Startups (15:42) The Visibility of Quality Careers in STEM (18:29) Demystifying Quality for Future Generations (21:12) Inspiring the Next Generation in Quality Science (22:40) The Emotional Impact of FDA Approvals (26:46) The Importance of Quality Leadership in Startups (31:30) Building a Quality Culture from the Ground Up (34:50) Advice for Future Quality Professionals (37:03) Making the Case for a Career in Quality
Twenty years at Merck, then a leap into academia and psychedelic medicine - here is how Dawn Lundin built a quality career on instinct. Dawn Lundin on the big pharma habits you have to unlearn in a startup. In today's episode I was joined by Dawn Lundin, founder of her own quality consultancy and a fractional Head of Quality across biotech and psychedelic-medicine companies. I really wanted to speak to Dawn because her path is nothing like the typical quality leader's. She didn't stay inside big pharma and climb one ladder. She spent twenty years at Merck, then walked into academia, then into one of the most stigmatised fields in medicine, and she made each move work. Dawn started as a bench chemist and grew through GLP, clinical packaging, GCP auditing and pharmacovigilance, eventually heading up issues management and co-authoring the first quality manual for Merck's research division. Then, on the morning of her twentieth anniversary, she resigned. She moved to the University of Pennsylvania to build fit for purpose quality systems for both sponsor and site research, a system still in use today. From there she stepped into psychedelic medicine for mental health, a move driven as much by personal loss as by professional curiosity. What runs through Dawn's whole story is a refusal to lead by importing an old playbook. In a smaller, faster environment she learned to do quality with far less, to put relationships before procedures, and to build trust before she changed a single thing. Her line for it has stuck with me: she did quality "one cup of coffee at a time." We talk about the following: Why she left twenty years at Merck on the exact morning of her anniversary The big pharma habits leaders have to unlearn in academia and startups How to build a fit for purpose quality system with a fraction of the resources Why relationships, not procedures, carry a quality programme in a small organisation The personal story that drew her into psychedelic medicine and mental health Dawn Lundin is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Dawn for sharing your incredible journey. Hope everyone enjoys the show. WHO THIS EPISODE IS FOR Quality leaders moving from big pharma into a startup, scale-up or academia Hiring managers building a first quality team and weighing up big pharma candidates Early-stage biotech founders who need fit for purpose quality without the overhead Quality professionals weighing a bold or unconventional career move Anyone drawn to how mental health and psychedelic medicine are being built responsibly Timestamps: (00:00) - Introduction to Dawn Lundin (01:15) - Dawn's Journey into Science and Quality (05:05) - Career Growth at Merck (11:16) - Transitioning from Big Pharma to Academia (17:34) - Navigating Startup Challenges (22:54) - Current Consultancy and Future Aspirations
Forty seven years in quality, and Tim Mitchell says the job he started is nothing like the one he does today. Tim Mitchell on how quality stopped being black and white In today's episode I was joined by Tim Mitchell, Vice President of Quality at Aktis Oncology, a radiopharmaceutical company in Boston developing treatments across several types of cancer. I really wanted to speak to Tim because very few people have watched quality evolve the way he has. He started in 1980, when the GMP regulations were barely a year and a half old and a quality assurance function did not really exist yet. Tim's story begins in a loud, industrial antibiotic fermentation plant, monitoring sixty to ninety thousand gallon fermenters that ran into the ground. His father worked in the neighbouring department at Eli Lilly, and an internship near his hometown turned into fourteen years at Lilly and a career that carried him from big pharma through to the start-up world he works in now. Along the way he moved from manufacturing into a validation team, without knowing what validation even was, and found that quality suited him. What comes through most is his view of the role itself. Tim does not see quality as a police force. He sees it as a collaborative partner to the rest of the business, a role that demands technical depth, patience and judgement. He talks openly about how the work has moved from black and white rule-following to something far more gray, especially in early-stage biotech where the science is moving faster than the rulebook. We talk about the following: How the quality function grew from a paperwork desk job into a value-adding partnership Why some of the best quality people come from manufacturing backgrounds The case for learning proper GMP systems in big pharma before joining a start-up What good mentoring actually looks like, and why annual reviews are not enough How the relationship between the FDA and biotech is becoming genuinely collaborative Tim Mitchell is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Tim for sharing your incredible journey. Hope everyone enjoys the show. WHO THIS EPISODE IS FOR Quality professionals moving from big pharma into a clinical-stage biotech Managers building or scaling a quality management system from scratch Manufacturing and technical operations people considering a move into quality VPs and Directors of Quality thinking about how they mentor their teams Anyone early in their quality career trying to understand where the role is heading Timestamps: (00:00) Introduction to Tim Mitchell and His Journey (02:27) Evolution of Quality in the Pharmaceutical Industry (05:07) The Changing Landscape of Quality Roles (07:59) Skills for Modern Quality Professionals (10:29) Mentorship and Team Development (13:16) The Future of Quality Leadership (16:20) Navigating the Transition from R&D to Commercialization (19:01) The Role of Quality in Biotech Innovation (21:12) Challenges and Opportunities in Quality Management (24:38) The Importance of Collaboration in Quality (27:07) Advice for Aspiring Quality Leaders
She came to the US with her first year's tuition and figured the rest out from there. What followed is one of the most grounded quality leadership journeys I have heard - and one we felt was worth bringing back. Swetha Krishnan on Building a Quality Mindset from the Ground Up This is a rerelease of one of our favourite episodes from two years ago. In today's episode I was joined by Swetha Krishnan. I really wanted to bring this conversation back because Swetha's route into quality was entirely unplanned - and the way she has turned that unplanned start into a clear leadership philosophy is something every quality professional should hear. Swetha came to the US from India to complete a master’s in bioengineering at the University of Toledo. She needed work, she needed a visa sponsor, and she found her way into a contractor role at Pfizer in Connecticut doing technical writing and validation. It was not the destination she had mapped out, but two years of being moved from role to role - quality management systems, regulatory content authoring, client-facing support - gave her a cross-functional view of how a pharma company actually operates. From there she moved through roles at Biogen, Sanofi Genzyme, and Alkermes before taking on her current position leading quality across all GXPs at Mural Oncology, a clinical-stage biotech focused on cytokine-based immunotherapies for cancer. Swetha leads with a combination of strategic clarity and genuine warmth. She is honest about the things she struggled with early on - particularly the belief that credibility required having all the answers - and equally clear about what changed that. She talks about the boss at Alkermes who told her she would one day be head of quality before she believed it herself, the nine-month Women Unlimited LEAD program that gave her two external mentors, and the MIT Leadership Signature course that asked her to examine what in her personal history shapes how she shows up every day. We talk about the following: • How a bioengineering thesis on non-invasive glucose measurement for diabetics led to an unexpected start in quality • Starting as a contractor at Pfizer and what wearing so many hats in two years taught her about the whole product life cycle • Why validation gave her a quality mindset before she had ever formally joined a quality team • The shift from individual contributor to manager to leader of teams - and why it forced her to rethink everything she thought she knew about credibility • The nine-month Women Unlimited LEAD program at Alkermes and the boss who saw her potential before she saw it herself • Quality by design in practice - being involved in CRO selection from the start, not after the contract is signed • How she manages prioritisation, managing up, and keeping her team grounded in a lean, fast-moving clinical-stage biotech • Her 4C model for aspiring quality leaders: challenge, curiosity, collaboration, and compassion Swetha is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. You can watch on LinkedIn Live at 12pm EST today or listen via Apple or Spotify. Thank you Swetha for sharing your incredible journey. Hope everyone enjoys the show. Who This Episode Is For • Quality managers and directors in clinical-stage biotech who are building systems and leading teams without large headcounts or unlimited budgets • Aspiring heads of quality who are in the transition from individual contributor to people leader and finding that shift harder than they expected • Quality professionals who came into the function from validation, technical writing, or another non-traditional route and are still making sense of how it all connects • Senior quality leaders who want a practical framework for developing the next generation on their team • Anyone in pharma or biotech who has ever felt like asking for help put their credibility at risk Timestamps: (00:00) Introduction to Swetha Krishnan and Mural Oncology (05:08) The Importance of Quality in Biotech (11:00) The Role of Quality in Driving Strategy (16:39) Managing Stress and Prioritization (21:55) Self-Development and Continuous Learning (26:44) Advice for Aspiring Quality Leaders
What does it really take to build a quality organization from the ground up - and do it again, and again, across multiple companies? Laura Singer on building quality that scales. In today's episode I was joined by Laura Singer, Vice President of Quality and Compliance at Loyal. I really wanted to speak to Laura because she has spent the better part of two decades walking into an early-stage biotech and building everything from scratch. Each time, a different product, a different regulatory landscape, a different team. And each time, the same fundamental challenge: how do you build quality infrastructure that is fit for today, but will not break tomorrow? Laura's career is a study in what it means to grow as a quality leader. She started in quality systems, realized she wanted more breadth, and made a deliberate move into a full GXP leadership role at Amicus as VP of Quality - a company that was developing its first commercial product for a rare disease. She came in as a senior director, proved herself, and earned the VP title. From there she spent six years at Heron Therapeutics building out an international quality function, and has since continued that pattern in successive roles. What makes Laura a compelling guest is not just the technical expertise - it is her philosophy. She talks about quality not as a compliance function, but as a business partner. She talks about leadership not as direction-giving, but as creating the conditions for other people to own their work. And she talks about the job of a quality head at the executive level with unusual clarity: you walk in with a plan, you are calm, you translate the regulations for the people around you, and you do not retreat when things go wrong. We talk about the following: • What it means to find your niche as a quality leader and how Laura discovered hers • Making the leap from a specialist quality systems role to a full GxP VP position without a network inside the company • How to communicate with a C-suite and executive team as a quality leader - and where most people get it wrong • What actually breaks in a quality system when a company scales from 40 to 140 people • How to define inspection readiness in practice, including the CDMO piece that often gets underestimated • Leadership philosophy, hiring for fit, and the importance of executive presence in quality Laura is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Laura for sharing your incredible journey. Hope everyone enjoys the show. WHO THIS EPISODE IS FOR • Quality leaders at VP and SVP level who are navigating the transition from compliance-focused to business-aligned quality leadership • Heads of Quality at early-stage biotechs who are building or scaling their quality function for the first time • Senior Directors and Directors of Quality who are ready to make the step up to VP and want to understand what that leap really looks like • Quality professionals at any level who want to build stronger relationships with their C-suite and executive team • Anyone in the life sciences who wants to understand what good quality leadership actually looks like in practice Timestamps: (00:00) Introduction to Laura Singer's Career Journey (05:47) Navigating Organizational Challenges (08:55) Effective Communication with Executives (12:06) Scaling Quality Systems in Organizations (17:34) Leadership Philosophy and Team Building (20:47) Managing Upwards and Sideways (24:26) Future Aspirations and Career Advice
From the lab bench to the C-Suite - and every crisis in between. In today's episode I was joined by Kimberly Garko, former Senior Vice President and Chief Technical Officer at Akebia Therapeutics. I really wanted to speak to Kim because her career trajectory is unlike almost anyone else I have interviewed on this show. She is a PhD virologist who began her career in the QC lab at Biogen, and over the following two decades built herself into one of the most accomplished quality and technical operations executives in the industry. She has led through warning letters, product recalls, complete response letters, workforce reductions, and commercial drug launches - often all at the same organisation. Her story is one of relentless curiosity, self-belief, and a genuine commitment to the patient at every stage. Kim talks about the pivotal moment early in her Biogen career when she was pulled out of the lab to help lead the effort to return Tysabri to market following its voluntary withdrawal. She discusses how that experience raised her ceiling permanently, and why she has never been able to go back to a smaller version of herself since. She shares how she thinks about building quality culture, identifying real leaders within an organisation, and what it actually takes to lead a team through a product recall at 3am on a Tuesday. We talk about the following: • How a JC virus safety crisis at Biogen changed the entire direction of Kim's career • What she looks for when she joins a new organisation and how she scales quality teams without losing culture • Her philosophy on 'creative compliance' and why the answer in quality is never just no • How to lead through warning letters, product recalls, and complete response letters without losing the team • The knowledge management crisis that follows every reduction in force and why most organisations are not prepared • What the Vafseo launch felt like after everything Akebia had been through • Her advice to quality leaders who want to reach the C-Suite Kimberly Garko is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in the most complex development environments imaginable. She has done this across biologics, oral solid dose, devices, and combination products at every stage from early clinical through to commercial launch. If you are a quality professional at any stage of your career - whether you are building your first team or trying to figure out what comes after VP - this episode is for you. Thank you Kim for sharing your incredible journey. Hope everyone enjoys the show. WHO THIS EPISODE IS FOR: • Quality leaders at director and VP level who are navigating high-pressure compliance situations and want a practical framework for crisis response • Aspiring quality executives who want to understand what it actually takes to move from functional leader to Chief Technical Officer • Quality managers in biologics, pharma, and biotech who want to build stronger, more resilient teams • Anyone who has ever had to manage a recall, a warning letter, or a workforce reduction and wants to hear from someone who has been through all three • Early-career scientists and QC professionals wondering whether there is a path to leadership from the lab bench Timestamps: (00:00) Introduction and Origin Story (03:41) The Tysabri Crisis and What It Built (09:48) Leadership Philosophy: People, Culture, and Scaling Quality (17:34) Turnarounds, Recalls, and Crisis Leadership (29:55) The Human Side: Celebration, Female Leadership, and Career Advice
Three BLAs. Three companies. One industry-defining challenge. Jake Trees, Irving Ford, and Megan Callan on What It Really Takes to Cross the Commercial Line in Cell and Gene Therapy In this special compiled episode of Let's Talk Quality, Hemish Ilangaratne brings together three quality leaders who have each led their organisation through one of the most demanding transitions in the industry: from clinical development to commercial manufacturing for a cell or gene therapy product. Jake Trees spent five years at Bristol Myers Squibb leading the quality function through the approval and launch of Abecma and Breyanzi, two of the first commercially approved CAR T cell therapies in the world. Irving Ford was the first quality hire at the Celgene cell therapy facility in New Jersey, built the QC organisation from nothing, and has since led quality through four BLA approvals across multiple cell therapy companies, most recently at Adaptimmune for the approval of Aucatzyl. Megan Callan is VP of Quality at Abeona Therapeutics, where she guided the quality team through the FDA approval of Zevaskyn, the first ever approved topical gene therapy for a rare genetic skin disorder. These are three distinct products, three distinct companies, and three distinct leadership journeys. But across all three conversations, the same themes surface: what it takes to build a quality team from scratch, how to shift the mindset of a clinical organisation towards commercial standards, and what the moment of approval actually feels like after years of sustained effort. In this episode, you will hear the following: Jake Trees on the setbacks on the road to BLA approval, including a refusal to file, cell growth failures during scale-up, and leading through a pandemic while hosting three health authority inspections Irving Ford on being the first quality hire at a new commercial cell therapy facility, building a team that grew to over 200 people, and why working in the gray is not a compromise but a core competency in this field Megan Callan on taking a quality team from five people to more than 60, coaching a clinical workforce into a commercial mindset, and what it means to empower people to make fast decisions when the patient is waiting This episode is for anyone who is working towards a first commercial approval, scaling a quality function in cell or gene therapy, or trying to understand what it takes to lead through the most demanding regulatory and operational environment in modern pharma. Thank you to Jake, Irving, and Megan for sharing their journeys. Hope everyone enjoys the show.
The non-linear path is often the most powerful one. Cinta Burgos on Building a Career Across Functions, Modalities, and Mindsets. In today's episode I was joined by Cinta Burgos, Senior Vice President of Quality and Regulatory CMC at New Amsterdam Pharma. I really wanted to speak to Cinta because her career does not follow the path you might expect for someone at SVP level. She has moved across pharma, medical devices, and biologics, held roles in quality engineering, validation, regulatory, and consulting, and built her executive presence not through a linear climb but through curiosity, flexibility, and a willingness to take opportunities as they came. Cinta's journey began with a biophysics degree, a near-completed master's in mechanical engineering, and early laboratory work on human growth factors and the varicella zoster vaccine. Life changed direction more than once - moving across the country, starting a family, building a consulting practice that spanned 17 years - and through each transition, she added a new dimension to her expertise. Today she leads quality assurance, quality control, quality systems, and CMC regulatory at a company she describes as scientifically driven, ethically led, and genuinely exciting. What stands out about Cinta is her philosophy of leadership. She talks about moving from task-oriented thinking to big-picture ownership, about not micromanaging the talented people around you, and about the importance of keeping a personal board of directors - mentors you check in with at different stages of your career. She is also candid about the moments where she did not immediately see an opportunity for what it was, and honest about what that taught her. We talk about the following: - How a biophysics background and an unfinished master's became an asset in a 30-year career - Why Cinta moved from R&D to validation to quality and what each transition taught her - The value of 17 years in consulting and the leadership jump it created - How quality professionals can move from task-oriented contributors to big-picture leaders - The role of AI in quality and manufacturing, and why human oversight is non-negotiable - Why quality voices are still largely absent from board-level conversations - What it means to treat everyone in your company as a quality professional Cinta Burgos is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Cinta for sharing your incredible journey. Hope everyone enjoys the show. Timestamps: (00:00) Cinta's Background and Career Start (03:14) Career Path: Pharma, Devices, and Biologics (06:02) Moving Across Functions: R&D, Validation, Quality (10:59) The Value of Cross-Functional Skills (14:17) Industry Collaboration and Remote Work (20:26) Future of Quality at the Board Level (22:55) AI in Pharma and Manufacturing (25:20) Advice for Aspiring Quality Leaders
From a graveyard shift in a generic drug lab to leading quality for one of the most advanced cell therapy programs on the planet - Mike Ruane's story is one every quality professional needs to hear. In today's episode I was joined by Mike Ruane, Head of Quality for In Vivo CAR-T at Bristol Myers Squibb. I really wanted to speak to Mike because his career is one of the more fascinating journeys I have come across in quality leadership. He has spent nearly two decades within what is effectively the same organisation, yet has lived through multiple acquisitions, spin-offs and complete pivots in therapeutic modality - each time emerging in a stronger, more interesting role than before. Mike began his career at APP Pharmaceuticals on a midnight QC shift, testing in-process samples on a graveyard schedule. From there, he followed the Abraxane asset into aBraxis Bioscience, built out supplier quality relationships across Central and South America, and eventually relocated from Chicago to New Jersey when Celgene consolidated its operations. That move opened the door to something entirely new - a CAR-T therapy program called BB2121 - a field Mike had never worked in and knew little about. Eight years later, he is now heading quality for in vivo CAR-T, one of the most cutting-edge modalities in all of biopharma. What makes Mike Ruane such a compelling guest is not just the breadth of his experience but his philosophy. He is a first-principles thinker who has thrived precisely because he never assumed the existing process was the right one. He asks the uncomfortable questions, encourages his team to do the same, and believes deeply that curiosity is the most underrated skill in quality. We talk about the following: How working in a lean generic drug environment early in his career shaped his mindset forever Navigating multiple acquisitions and spin-offs within a single career arc What it takes to step into an entirely new therapeutic modality with no prior experience Why curiosity and asking the right questions is the real engine of career growth in quality How he interviews candidates and what most people get wrong when they are being interviewed Mike Ruane is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Mike Ruane for sharing your incredible journey. Hope everyone enjoys the show. Timestamps: (00:00) Introduction to Mike's Career Journey (02:01) Transitioning Through Acquisitions and Roles (06:39) Navigating Supplier Quality and External Partnerships (11:05) The Shift to CAR T Therapy (16:05) The Importance of Asking Questions (20:48) Advice for Future Generations
CAR-T Saved Her Life. Why Can’t Most Patients Access It? In today’s episode I was joined by Laurie Adami, cancer survivor, patient advocate, and one of the most impactful voices I’ve had on the podcast. I first spoke to Laurie a couple of years ago, and her episode is still one of the most listened to we’ve had. Laurie went through a 12-year cancer journey, six lines of therapy, multiple relapses, clinical trials… and ultimately, in 2018, her 7th treatment, CAR T-cell therapy which saved her life and finally for the first time in 12 years put her in a complete remission. Now, two years on, she’s back. Still in a complete remission and requiring no further treatment nearly 8 years post CAR T infusion, Laurie is now considered cured even though her cancer is still labeled incurable. But what stood out to me in this conversation is that while the science has progressed… many of the systemic challenges patients face haven’t. We talk about the following: · What life actually looks like after being “cured” of cancer · The long-term side effects of 12 years of treatment · Why most biotech and pharma professionals have never spoken to a patient · The reality behind “patient centricity” in the industry · Why 80% of eligible patients still can’t access CAR-T therapy · The biggest bottlenecks in access - awareness and insurance · The financial burden of cancer treatment in the US · Where real progress is being made in cell and gene therapy · The future of CAR-T in autoimmune diseases and beyond · Laurie’s memoir and why every biotech employee should read it This is an honest conversation about the gap between scientific progress and real-world patient impact. A huge thank you to Laurie for returning to the show and tell her story again! The work she is doing to help raise awareness is inspiring, and I’d urge anyone to connect with Laurie and follow her journey. If you work in biotech, pharma, healthcare, or you’d like to learn more about the challenges this industry still faces… this is one you need to hear. Timestamps: (00:00) A Journey of Survival and Remission (02:28) Life After CAR-T: Misconceptions and Realities (05:35) The Ongoing Battle: Side Effects and Daily Life (08:30) Patient Advocacy: Bridging the Gap with Pharma (11:00) The Disconnect: Patient Needs vs. Industry Understanding (13:48) Access and Awareness: The Challenges of CAR-T Therapy (16:36) The Future of CAR-T: Innovations and Progress (19:30) Writing a Memoir: Sharing the Patient Experience
Perseverance, perspective and people-first leadership in a global quality role. In today's episode I was joined by Burak Begen, Head of Global Manufacturing Quality at Siemens Healthineers. I really wanted to speak to Burak because he’s built his career across multiple countries, cultures and challenges, and now leads quality across global manufacturing sites. His journey gives a very real view of what it actually takes to operate at that level. Burak’s career hasn’t been linear or easy. From starting his career in Turkey, moving to the US for his PhD, rebuilding his career from scratch, and navigating setbacks like job losses and site closures - his story is defined by perseverance and resilience. What stood out is how those experiences shaped the way he leads today. He leads from the front, sets high standards, but always stays close to his teams. Whether it’s staying late to close records or travelling globally to connect with people on site, his leadership is grounded in accountability and support. We talk about the following: Why perseverance is a defining trait for quality leaders Leading global teams across time zones and cultures Building a partnership mindset in quality instead of a “policing” approach Creating the right KPI culture and avoiding “watermelon metrics” Empowering teams to make decisions and building psychological safety If you are a quality professional managing multiple sites a leader struggling with KPIs, culture or engagement across sites, or someone who wants to step into a larger global role, then this episode is for you. Thank you Burak for sharing your incredible journey. Hope everyone enjoys the show. Timestamps: (00:00) Introduction to Burak Begen (06:00) The Importance of Quality in Leadership (10:39) Cultural Influences on Leadership (16:11) Navigating Time Zones and Cultural Differences (21:03) The Role of KPIs in Quality Management (27:51) Looking Ahead: Future Aspirations
Great quality leaders don’t just build systems - they build people, culture and confidence. In today's episode I was joined by Melodie Bryce, Chief Quality Officer at Kincell Bio. Melodie’s journey is a brilliant example of how diverse experience across manufacturing, supply chain, training and quality can shape a well-rounded quality leader What stood out most is her approach to leadership. Melodie focuses heavily on building strong teams, developing future leaders and creating an environment where people are supported but also expected to take ownership. She combines high standards with a genuine commitment to coaching and mentorship. We talk about the following: · How to assess a quality organisation when you first join · Why hiring “stronger than you” is critical to building high-performing teams · What makes a great quality leader in fast-growing biotech environments · The importance of being a self-starter in quality roles · How to develop future leaders through coaching and mentorship · What to look for in the first two weeks of hiring someone · Leading through remediation and why it accelerates growth · Building a quality culture where everyone takes ownership · Balancing compliance with real-world decision making in cell therapy · Why “digging deep” is the foundation of leadership success Melodie is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality leader looking to develop stronger teams and future leaders, then this episode is for you. Thank you Melodie for sharing your incredible journey. Hope everyone enjoys the show. Timestamp: (00:00) Introduction to Quality Leadership (04:01) Challenges in Quality Leadership (06:15) Developing Future Leaders (08:33) Hiring for Success (11:01) Assessing New Hires (13:57) Leadership Evolution (16:04) Cultural Insights in Quality (18:56) Advice for Aspiring Leaders
If you are the first quality hire in a startup, your job is not to build everything at once. Your job is to build the right things first. That was one of the clearest takeaways from my conversation with Rex Ready on Let’s Talk Quality. A few practical points he shared stood out: · Follow the path of the product · Understand the patient experience · Focus first on what directly affects patient safety · Build procedures around processes that already work · Prioritise quality investment based on stage, modality, and risk In early-phase environments, it is easy to create a long list of things you would like to have. An EQMS. A fuller audit programme. More formal vendor oversight. A bigger team. All of that matters. But not all of it matters equally on day one. Strong quality leadership is about judgment. It is about knowing what must be in place now, what can come next, and how to build trust while you do it. That is especially true in cell and gene therapy, where complexity is high and patient impact is immediate. A very strong conversation with Rex, and a useful one for anyone building quality in a lean biotech environment. Timestamps: (00:00) Introduction (02:30) From Funeral Director to Biotech: A Unique Path (05:47) Early Experiences in Quality Control (07:26) Leadership in Quality: Building Relationships (09:57) Vision for the Future: Drug Development and Quality (15:04) Building Effective Relationships in Quality (17:59) Prioritizing Quality in a Lean Team (22:58) Planning for Future Growth in Quality (28:01) Reflections on Cell and Gene Therapy
Quality is changing. The systems are getting smarter, the data is getting bigger, and the people side is still the hardest part. This week, I sit down with Dennis Rodman, Senior Director of Quality Management Systems and Digital Compliance at Intellia Therapeutics. Dennis brings a rare perspective to quality. With 13 years at BMS across operations, technical services, and quality, he now helps a gene editing company prepare for its first commercial product. In this episode, we explore: Why quality should be value-add, not a compliance hammer What separates companies that get digital transformation right from those that don't How to choose the right QMS without getting sold something you don't need Why AI isn't delivering the ROI people expected, and what's going wrong How to manage change when most people don't want it What early-career quality professionals should be doing right now to accelerate A practical, honest conversation for anyone working at the intersection of quality, systems, and people. Timestamps: (00:00) Introduction and Background (05:04) Quality Management Systems and Operations (09:59) Stakeholder Engagement and Change Management (15:12) The Role of IT in Quality Management (21:02) Cultural Shifts and Data Sharing (23:34) Advice for Aspiring Quality Leaders (26:01) Future of Biotech and Quality Management
From accidental quality professional to global quality leader - Valerie Brown's story is one of courage, curiosity, and conviction. In today's episode I was joined by Valerie Brown, Head of Global Quality Assurance and Compliance at Thermo Fisher Scientific's Clinical Research Group. I really wanted to speak to Valerie because she brings something different to the quality leadership conversation. Yes, she has held senior quality roles across innovator companies, CDMOs, and now one of the largest CROs in the world. But what makes her story compelling is how she got there - and what she learned along the way. Valerie didn't plan to work in quality. At 22, she was asked to be a scribe for an FDA inspection. The host fell ill on the day. She stepped in - no preparation, no safety net - and handled it. Someone told her she had a knack for it. She wasn't sure she agreed. She still wanted to be in the lab, in manufacturing, doing what she knew. But that moment planted a seed. What followed was a career that took her across CDMOs, innovator companies including Gilead Sciences, and now Thermo Fisher - where she leads global quality assurance and compliance for the clinical research group. She has sat on both sides of the table, as sponsor and as service provider, and that experience shapes everything about how she leads. We talk about the following: How Valerie accidentally became a quality professional, and why that unplanned start shaped everything that followed What it felt like to host an FDA inspection at 22, with no preparation and no safety net Her philosophy of servant leadership and what it really means to lead with empathy in a regulated environment The challenge of transforming a fragmented quality organisation into a connected, strategic function at Thermo Fisher The difference between working on the innovator side versus the CRO side - and the unique skill set the latter demands Why speed and quality are not in conflict, and how embedding quality by design from the outset actually accelerates delivery Her approach to talent development - why she prefers to grow leaders from within and how she identifies that potential early The growing importance of AI and digital governance in regulated environments, and why quality professionals need to engage with these tools now What keeps her up at night heading into 2026 - from talent gaps to trial complexity to the pace of regulatory change The advice she would give her younger self, and what she believes every aspiring quality leader needs to understand Valerie Brown is a highly accomplished global quality leader whose career is a masterclass in adaptability, influence, and patient-centric thinking. She leads with purpose, develops people with intention, and approaches every challenge with the mindset of a problem solver - exactly the kind of leader our industry needs more of. Thank you Valerie for sharing your incredible journey. Hope everyone enjoys the show! Timestamps: (00:00) Introduction to Valerie Brown and Her Journey (02:59) Valerie's Leadership Philosophy and Style (06:00) Transitioning from Innovator to CRO: Insights and Challenges (11:04) Quality Assurance in Clinical Research: A New Perspective (13:58) Building a Quality Organization: Strategies and Goals (20:55) The Role of AI in Quality Management (24:18) Future Goals and Challenges in Quality Assurance (29:04) Advice for Aspiring Quality Leaders
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 themselves Dana 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! Timestamps: (00:00) Introduction (01:43) Early Challenges in Career Growth (10:37) Midlife Awakening (18:06) Embracing Authenticity in Leadership (28:08) The Importance of Being Seen
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 quality Anthony 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 out Which modalities and parts of the market feel resilient, and which are still struggling How FDA leadership changes are (and aren’t) showing up in day-to-day work The shift toward written-only FDA interactions and what that means for sponsor–agency relationships Whether regulators are prioritising speed or risk, and how that tension plays out Where AI and digital tools are genuinely adding value today, versus where there’s still a lot of noise How Quality has evolved from “policing” to partnership over the last 20 years Why pragmatic, phase-appropriate Quality systems matter more than perfection Burnout in senior Quality leaders and the risk of doing too much with too few people What separates Quality leaders who are listened to from those who are merely tolerated What the strongest Quality teams will be doing differently by the end of 2026 Ed 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 3 The moment she realised she needed to stop firefighting and start planning How she built the quality team around her to enable strategic thinking The soft skills that shape strong future QA leaders How to balance urgent deliverables with long-term quality strategy Why confidence is essential before others trust you as a strategic partner Elisabeth 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.
