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From Cost Center to Value Driver: Rethinking Quality in the Life Sciences with Marcia Baroni

Author
The FDA Group
Published
Tue 08 Jul 2025
Episode Link
https://podcasters.spotify.com/pod/show/the-fda-group/episodes/From-Cost-Center-to-Value-Driver-Rethinking-Quality-in-the-Life-Sciences-with-Marcia-Baroni-e359757

Nick Capman talks with Marcia Baroni—a microbiologist with 27 years in global pharma-quality leadership—about reframing quality from a controllable expense to a strategic asset.

Baroni contrasts “bad-quality” costs (scrap, recalls, deviations) with “good-quality” investments (testing, preventive controls, oversight) and explains why the latter pay for themselves in resilience and brand value. She illustrates the stakes with a $600 million nationwide OTC-drug recall caused by chemically treated pallets—an error frontline staff flagged but a weak quality culture ignored.

The conversation dives into building psychological safety and metrics that drive the right behaviors, not under-reporting, shifting quality from “policing” to cross-functional partnership, and practical first steps executives can take to gauge their current maturity and start investing for future yield.

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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/

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