Navigating FDA, Reliability, and Quality Leadership | with Jeff Gensler

Welcome to the first episode of the Navigating the Combination podcast!

When Jeff Gensler walked into Pfizer Meridian on day one, FDA had left the building just a week earlier. What followed — a warning letter response, 15 FDA meetings in four months, a CDRH site audit, and an agency directive to redesign the entire product — was a challenge, but also an opportunity for in-depth examination of the company’s quality systems.

In this episode, Jeff joins Parth Kothari and Jonathan Amaya-Hodges to unpack those early days, the gaps he found between pharma and device quality thinking, and how that experience shaped his entire approach to process capability, CAPA, and compliance. Jeff breaks down why the transition from attribute to variable data is so much more than a methodology switch — and shares a real example of how catching a single worn mould cavity early saved millions of dollars in scrapped components. He also makes the case for why quality professionals need to stop speaking compliance-only and start building business cases that leadership can actually act on. Now Chief Quality Officer at Exela Pharma Sciences, Jeff reflects on what the shift to the CDMO space looks like, where the industry is heading, and why he believes quality is becoming a competitive advantage rather than a cost center.

Key takeaways:

• Pharma and device quality systems differ fundamentally in CAPA philosophy – pharma treats CAPA as actions from investigations, while device uses it systemically for trend violations and major issues
• Switching from attribute to variable data requires process improvement work first — you’ll surface capability gaps that were invisible before Variable data allows earlier detection of process drift, as demonstrated by catching a degraded mould cavity before a single out-of-spec part was produced
• Quality improvements need a business case, not just a compliance argument — linking changes to cost savings significantly increases the chance of leadership buy-in
• Process validation should go deeper than IQ/OQ/PQ checkboxes — centring processes within OQ limits prevents failures down the line
• Continuous process monitoring catches variation sources that a three-lot PQ simply cannot represent CDMOs are often out of sight with FDA — building a proactive quality culture internally is both a compliance strategy and a market differentiator
• Run towards the fires — warning letters, drug shortages, and enforcement actions are where quality professionals learn the most, fastest

Connect with Jeff Gensler on LinkedIn.

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We hope you enjoy this episode! 

What is Navigating the Combination? Watch the below quick intro video…

AUTHOR

Jonathan Amaya-Hodges, Vice President, Technical Operations, Suttons Creek – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.