Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
About this episode
Jackie Klecker discusses building phase-appropriate quality systems in life sciences from preclinical to commercial stages.
Scaling a product from preclinical development to commercial manufacturing is one of the most complex transitions life science teams face—and one of the easiest places to lose time and momentum. In this episode of The Life Science Rundown , host Nick Capman speaks with Jackie Klecker , Executive Vice President of Quality and Development Services at Lifecore Biomedical , about how sponsors and CDMOs can build robust, phase-appropriate quality systems without over-engineering early or under-preparing later. Drawing on decades of experience across pharmaceutical drug products, medical devices, APIs, and biologics, Jackie shares practical guidance on knowledge transfer, risk management, QMS maturity, and regulatory expectations across the U.S. and EU. The conversation focuses on what actually prevents costly delays—and how disciplined communication and documentation make scaling achievable. A few key takeaways: Early quality work should be right-sized , not commercialized prematurely Design space, material variability, and sensitivities must be understood and documented early FMEA works best when it evolves with the product—not when it’s treated as a one-time exercise FDA and EU…
More episodes of The Life Science Rundown
- TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
- Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That
- Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
- Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
- Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson
- Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
Explore listener stats, chart rankings, contacts and more on the The Life Science Rundown podcast page.