Episode
From Virologist to CTO: Leading Quality Through Crisis, with Kimberly Garko
- Podcast
- Let's Talk Quality
- Published
- May 12, 2026
- Duration seconds
- 2222
- Processing state
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Summary
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 cri…