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Kivo Innovation Theater: Nothing Changes Unless We Do - Implementing QMS with CRISPR Therapeutics in 52 Days
Session Chair(s)
Kivo, Inc.
, United States
Quality improvement rarely starts with a blank slate — but what happens when it does? When CRISPR Therapeutics faced a contract deadline and an overly complex QMS, they chose disruption over incremental fixes, rebuilding their Quality processes from the ground up in just 52 days. In this session, CRISPR's Executive Director of Quality and Pharmacovigilance Operations, Kate Ellmer, and Kivo's VP of Services, Chris Xistris, share how stripping away the bells and whistles revealed a simpler, more effective path forward. Walk away with a practical framework for right-sizing your QMS, evaluating vendors under pressure, and turning operational constraints into a catalyst for real change.
Learning Objective : How to think about Quality Management Systems from an entrepreneurial perspective; What “right-sizing” a Quality system means for smaller / scaling organizations; Concrete examples of simplified processes; What to look for when exploring a new system.
Speaker(s)
Kate Ellmer, MPH
Exec. Director, Quality and PV Operations, CRISPR Therapeutics, United States
Speaker
Chris Xistris
Vice President of Services, Kivo, United States
Speaker
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