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