The FDA Group's Nick Capman sits down with Dr. Kimberly Garko, Chief Technical Officer and 25-year life science veteran, for a deep dive into one of the most misunderstood concepts in the industry: the cost of quality.

Dr. Garko shares why quality should be viewed not as a cost center but as a strategic investment—and how companies can embed that mindset into their culture, systems, and leadership practices. She outlines the difference between good and poor quality costs, explains how to build ROI-focused metrics, and offers practical ways to foster transparency, psychological safety, and proactive decision-making.

From regulatory intelligence and scorecard design to audit readiness and AI integration, this conversation is packed with insights for quality leaders and executive teams alike.

What they cover:

How to shift your organization’s mindset from compliance to value creation
The real financial and operational impact of poor vs. proactive quality
How to build scorecards, systems, and reporting processes that drive action
Why culture, transparency, and psychological safety are core to sustainable quality
Practical approaches to audit readiness, supplier oversight, and training

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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit ⁠⁠https://www.thefdagroup.com/

Quality Is Not a Cost Center—It’s a Culture (with Dr. Kimberly Garko)

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