“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.
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September 29, 202641 min
Colleen Walson-Billin on Building a Quality Career Without a Science Degree
Colleen Walson-Billin was told she was not eligible to progress in Quality without a science degree, and went on to lead a full GxP Quality function at a biologics startup. Colleen Walson-Billin on building a Quality career without a science degree. In today's episode I was joined by Colleen Walson-Billin, Vice President & Head of GxP Quality & Compliance at Jade Biosciences. I wanted to speak to Colleen because her route into Quality started with a business degree and a role as administrative assistant to a director of Quality at Amgen. From there she moved through QA, corporate and international Quality, served twice as chief of staff to the head of Quality, and now leads Quality across GMP, GCP, GLP and pharmacovigilance. We talk about: Starting in Quality as an administrative assistant, and telling her first boss up front that the role was her foot in the door Being told she was not eligible to progress without a science degree, and building her technical knowledge on the job Serving twice as chief of staff to the head of Quality, and what she learned at the table with the leadership team Leaving Amgen for smaller companies, and picking up GCP, GLP and pharmacovigilance for the first time Leading executive and senior directors, stepping back from being the doer, and positioning Quality as a partner from the start Thank you Colleen for sharing your journey. Timestamps: (00:00) Introduction (00:46) "My foot in the door": business degree to admin assistant (05:02) "You're just not even eligible" (08:51) The advice that made the degree stop mattering (12:34) A career with no plan, built by putting her hand up (19:14) Leaving Amgen for a smaller company (22:01) Employee number 24, and "enough to be dangerous" across GxP (25:14) Why the degree becomes almost irrelevant at 20 years (29:50) Roadblocks, naysayers and the police: old school Quality (35:06) Selling Quality to a room of college students (40:03) Inspired by what she did not want to become
September 22, 202641 min
Geetu Abbi on When to Build a Digital Quality Function
Geetu Abbi was handed the GAMP guide as a new validation engineer at Genzyme, and in 2024 she co-led one. Geetu Abbi on When to Build a Digital Quality Function In today's episode I was joined by Geetu Abbi, Head of Digital Quality Assurance at Alkermes. I wanted to speak to Geetu because Digital Quality was not a job title eight to ten years ago, and she has grown into the role from computer systems validation. She moved from software testing into validation at Siemens without a life sciences background, and in 2024 she co-led the GAMP guide for GCP and clinical trials. We talk about: - Moving from software testing into validation at Siemens, with no prior exposure to Part 11 or 21 CFR 820 - What Digital Quality is, and the gap it fills between site Quality and clinical Quality - Data lifecycle mapping, and why validation now has to be revisited with every change - Delivering seven validated systems in eight months to support the Alkermes-Mural Oncology separation in 2023 - Her advice to the next generation of Quality professionals on why they don't have to solve everything alone Thank you Geetu for sharing your journey. Timestamps: (00:00) Introduction and guest background (03:42) From QA to validation (08:00) Career turning point (13:04) What digital quality means (22:28) Digital quality as a career opportunity (29:58) How the team is structured (34:06) Advice for future quality leaders
September 11, 202636 min
Isha Patel on the Overnight Career Plan That Took Her from Associate Director to SVP
Naymisha (Isha) Patel has spent thirty years in Quality and regulatory compliance across pharmaceuticals, biologics, medical devices and combination products. She is now Senior Vice President of Quality at AirNexis Therapeutics, a seven-month-old startup developing a combination product for COPD, where she is the first Quality hire. In this episode Isha talks about the ten-year career plan she wrote overnight in 2005 after a hiring VP at Nektar asked what she wanted, and how it carried her from associate director to senior vice president. She explains why she moved to Boston in a blizzard to lead Quality at Ocular Therapeutix, a one-product company with two FDA complete response letters, and what she found in the inspection scribe notes. She walks through the reorganisation, letting go of people whose skill sets did not match the product classification, and the FDA inspection that ended in approval with no post-approval commitments. Isha also covers building Tenaya's Quality function, closing that same manufacturing facility four and a half years later, and choosing between consultants and permanent headcount. Topics covered: - Why a career plan written on paper beats a vague ambition - Reading the scribe notes, not just the CRL - Letting people go for skill fit, not performance - What FDA inspectors want to see when you are not finished - Green flags when a CEO hires their first head of Quality - Consultant or permanent hire: the two-year vision test - Why Quality is missing from early-stage boards - Quality as navigating grey zones, not yes or no Timestamps: (00:00) Introduction and guest background (02:52) Transitioning into Quality leadership (06:34) Career moves and a pivotal opportunity (08:38) A practical career plan (13:13) Turning around a Quality system (20:21) Building Quality in gene therapy (22:14) Choosing the right startup role (25:42) Building a lean Quality team (28:09) C-suite and board aspirations (30:10) Advice for aspiring Quality leaders
September 1, 202639 min
Dawn Houlihan on Her Journey From Ireland Big Pharma to the Boston Start-Up World
Dawn Houlihan started out as the person manufacturing teams went quiet around, and spent the next twenty years proving that quality works better as a partner than a police force. Dawn Houlihan on Her Journey From Ireland Big Pharma to the Boston Start-Up World In today's episode I was joined by Dawn Houlihan. I wanted to speak to Dawn because she has built a quality function from nothing, and has done it across almost every stage and modality the industry has to offer. She spent half her career with Janssen in Ireland, moved to Scotland and then to Boston, and has since led quality through phase three, commercial approval and cell and gene therapy in two small companies where everything was outsourced. We talk about: What quality was actually like on the manufacturing floor in Ireland in the mid two thousands The mentor who told her to say yes to a project she did not have time for Switching CDMO in the middle of phase three and still hitting commercial approval Why saying no to everything is the easy road, and what it costs a small company Being the first quality hire at Ensoma and building the culture from scratch Timestamps: (00:00) Introduction and Dawn's background in pharma (05:03) Quality's evolution: from policing to partnership (07:20) Mentorship, Scotland, and the move to Boston (13:10) Building quality teams in biotech startups (19:09) Trust, risk, and leading through partnership (29:29) Building quality from the ground up (34:16) The future of quality leadership and career advice
August 25, 202639 min
Luciana Mansolelli on Her First Year as CQO in the CDMO World
Luciana Mansolelli spent twenty years on the sponsor side. One question from a board chairman moved her to a CDMO. Luciana Mansolelli on her first year as CQO in the CDMO world. In today’s episode I was joined by Luciana Mansolelli, Chief Quality Officer at Minaris Advanced Therapies. I wanted to speak to Luciana because she has now led quality on both sides of the same relationship - Novartis and J&J on the sponsor side, and now a 200-person global quality organisation across the US, Germany and Japan. We talk about: • The moment she realised she had stopped learning, and why she left • Why framing speed against quality is the wrong model in advanced therapies • How she structured a global quality team around the science rather than the org chart • What she assesses for when she hires, beyond technical competence • Turnover in the CDMO world, and why she thinks capability is the fix Thank you Luciana for sharing your journey. Timestamps: (00:00) Introduction to Luciana Monsolelli (01:01) Journey into Pharmaceutical Sciences (02:41) The Evolution of Quality in Pharma (05:32) Transitioning from Big Pharma to CDMO (08:30) Challenges in the CDMO Landscape (14:00) Building a Quality Culture at Minaris (19:00) Talent Management and Capability Development (27:00) Leadership Style and Team Dynamics (37:00) Future Aspirations in Advanced Therapies
July 30, 202616 min
My Thoughts on Quality Leadership, Halfway Through Season Four
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
July 21, 202638 min
Speaking the Language of the Business, with Jamey Lindholm
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
July 14, 202629 min
The Big Pharma Habits You Have to Unlearn in a Startup, with Dawn Lundin
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
July 7, 202633 min
How Quality Stopped Being Black and White, with Tim Mitchell
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
May 26, 202641 min
Swetha Krishnan on her journey from Individual Contributor to Inspiring People Leader
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
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