Episode
Speaking the Language of the Business, with Jamey Lindholm
- Podcast
- Let's Talk Quality
- Published
- Jul 21, 2026
- Duration seconds
- 2306
- Processing state
not_requested
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Summary
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…