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