# LTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era

Page: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-143-jennifer-mascioli-tudor-on-leading-proactive-quality-in-the-qmsr-era
Text version: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-143-jennifer-mascioli-tudor-on-leading-proactive-quality-in-the-qmsr-era.md
Podcast: [Let's Talk Risk! Podcast](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844)
Published: 2026-02-13T13:00:00+00:00
Episode link: https://naveenagarwalphd.substack.com/p/ltr-143-jennifer-mascioli-tudor-on-leading-proactive-quality-qmsr
Audio file: https://api.substack.com/feed/podcast/186981948/326edfcac623f53f0341bc9ee8c56062.mp3
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Duration seconds: 1832

## Resource

Summary “Management review is no longer a check-the-box exercise. It’s the most powerful lever leaders have to drive proactive quality.” In this episode of the Let’s Talk Risk Podcast , Naveen Agarwal sits down with Jennifer Mascioli-Tudor , an experienced Quality and Regulatory leader, to unpack what QMSR readiness really means in practice. Jennifer shares what she’s seeing across the industry, from companies that are fully prepared to those that haven’t started, and explains why being ISO 13485 certified is not enough. The conversation dives deep into FDA inspection behavior, closed-loop risk management, management review as a leadership tool (not a formality), and the very real consequences of reactive quality systems. This episode is a must-listen for quality, regulatory, and executive leaders who want to move beyond compliance and build proactive, inspection-ready organizations. Chapters 00:00 Welcome and Introduction 02:20 ISO 13485 vs FDA inspections: where assumptions break down 03:40 Closed-loop risk management across the total product lifecycle 05:40 How FDA uses complaints, CAPA, and trends to escalate inspections 09:35 Leadership mindset shift: from reactive fixes to proactive quality 11:35 Management review as a strategic decision-making forum 20:25 Inspection readiness as culture, practice, and people, not paperwork If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter . Suggested links: * LTR: QMSR Readiness, Risk-Based Assurance and FDA Expectations . * LTR: 90-Day QMSR Readiness Action Pan for Leaders . * LTR: FDA Readiness for QMSR . Key Takeaways * Don’t wait for FDA to expose your gaps, identify and document them yourself * Treat QMSR as a strategic initiative, not a quality department project * Use management review t…

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## Transcript

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