Let's Talk Quality

This is Small Dose, our new weekly series of short clips from Let’s Talk Quality.

This week’s clip is from Episode 1 of Season 1, with Jaspreet Gill.

Listen to the full episode on:

Apple Podcasts: https://podcasts.apple.com/us/podcast/jaspreet-gill-on-scaling-quality-functions-and/id1701837660?i=1000623944697

Spotify: https://open.spotify.com/episode/6GI4vJjMP0pUYYn7NTgtYy

Connect with Jas on LinkedIn: https://www.linkedin.com/in/jaspreet-gill16/

Maja Pedersen says following a process is what she does least, and she built a career in Quality because a clear framework gives people room to make pragmatic decisions.

Maja Pedersen on AI, Strategic Leadership, and Evolving as a Quality Leader

In today's episode, we revisit a conversation with Maja Pedersen from July 2025. Maja is now President and Chief Operating Officer at FUJIFILM Biotechnologies. When we recorded this conversation she was Chief Quality Officer, responsible for six sites with a seventh being built in Japan. I really wanted to bring this conversation back because she moved from a TrackWise rollout in medical devices to leading Quality, IT, digitalization and science across a global CDMO. She is at the forefront of AI adoption, and her approach to Quality leadership is built around people and a pragmatic framework.

We talk about:

• How Maja went from a TrackWise rollout in medical devices to leading a Quality team early in her career
• Taking over a Quality team of roughly 30 at Cook Medical and understanding people before trying to be understood
• Becoming site head of Quality at Biogen in Hillerød and learning to perform through her team
• Leading a global team across six sites, including four in-person meetings a year and meditation at the last leadership summit
• Why she wants Quality to move from correction to prediction, and why she recommends putting Quality and IT under one leader

Thank you Maja for sharing your journey.

Timestamps:

(00:00) Quality, IT, digitalization and science under one leader

(02:45) Why following a process is what she does least

(13:34) Inheriting a team of 30 and presenting yourself as a human being

(21:56) Moving from tactical to strategic thinking

(27:32) Too loud about AI, and how IT landed on her desk

(33:06) A global team that meets four times a year and meditates together

(38:51) At least an hour and a half of daylight, every day

(42:28) Corrections more than preventions: where Quality goes next

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

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

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

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

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

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