From Virologist to CTO: Leading Quality Through Crisis, with Kimberly Garko

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 crisis that follows every reduction in force and why most organisations are not prepared

• What the Vafseo launch felt like after everything Akebia had been through

• Her advice to quality leaders who want to reach the C-Suite

Kimberly Garko is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in the most complex development environments imaginable. She has done this across biologics, oral solid dose, devices, and combination products at every stage from early clinical through to commercial launch.

If you are a quality professional at any stage of your career - whether you are building your first team or trying to figure out what comes after VP - this episode is for you.

Thank you Kim for sharing your incredible journey.

Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR:

• Quality leaders at director and VP level who are navigating high-pressure compliance situations and want a practical framework for crisis response

• Aspiring quality executives who want to understand what it actually takes to move from functional leader to Chief Technical Officer

• Quality managers in biologics, pharma, and biotech who want to build stronger, more resilient teams

• Anyone who has ever had to manage a recall, a warning letter, or a workforce reduction and wants to hear from someone who has been through all three

• Early-career scientists and QC professionals wondering whether there is a path to leadership from the lab bench

Timestamps:

(00:00) Introduction and Origin Story

(03:41) The Tysabri Crisis and What It Built

(09:48) Leadership Philosophy: People, Culture, and Scaling Quality

(17:34) Turnarounds, Recalls, and Crisis Leadership

(29:55) The Human Side: Celebration, Female Leadership, and Career Advice