24: Decoding GMP Supplier Oversight by Applying QRM with Confidence
In this episode, we're decoding what effective GMP supplier oversight really looks like—and how sponsors can apply Quality Risk Management (QRM) principles to build smarter, more sustainable programs. We will cover supplier oversight, ongoing performance monitoring, and risk-based decision-making, with practical insights and a focus on what matters most: protecting product quality and patient safety.
Whether you’re building a supplier oversight program from the ground up or refining what’s already in place, this episode delivers the tools and mindset shifts sponsors need to lead with intention and compliance.
This month's guest is Rosanna Bules, a Certified Quality Auditor. Rosanna is a strategic and results-driven Quality Assurance Leader with 17+ years of biopharmaceutical experience (commercial and clinical), specializing in GMP Supplier Quality Management (SQM), audits, regulatory compliance, and risk-based quality oversight. Expertise in developing risk-based programs, conducting domestic and international audits, establishing and negotiating quality technical agreements (QTAs), and fostering cross-functional collaboration to ensure compliance with global regulations/guidelines. Proven track record in designing/developing processes, improving/streamlining existing processes, leading teams, and delivering measurable improvements in supplier oversight and management.
This month’s show notes include:
Link to Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 1
Link to Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 2
Link to FDA Chapter 56 Drug Quality Assurance: Outsourcing Facility Inspections
Link to Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
Link to FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements
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23: From Battlefields to Biopharma: Knowledge Management in High-Risk Worlds
In this compelling Risk Revolution episode, Valerie Mulholland chats with Barry Byrne, Head of Knowledge Management Strategy at Novartis and a former Irish military officer. Barry shares his journey from Lebanon’s conflict zones to global pharma, revealing how real-time knowledge sharing can save lives, not just on the battlefield but also in medicine. They explore the transformative power of AI, storytelling, and sense-making in regulated environments, and what pharma can learn from NASA, the military, and consulting giants—a must-listen for leaders driving cultural and knowledge change in high-stakes industries.
This month’s show notes include:
Links to the knowledge summit https://www.knowledgesummitdublin.com/
Links to David Snowdon’s Cynefin website https://thecynefin.co/
The Work of the PRST – Marty Lipa & Paige Kaine https://prst.ie/
TED TALK by the author of Turn the Ship Around, David Marquet https://www.youtube.com/watch?v=HYXH2XUfhfo
BOOK: Turn the Ship around: Turn the Ship Around!: A True Story of Turning Followers into Leaders by David Marquet (Author), Stephen R. Covey (Foreword – 7 habits of Highly Effective People)
BOOK: A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry (Biotechnology and Bioprocessing by Nuala Calnan, Marty Lipa, Paige Kane and Jose Menezes
BOOK: The Checklist Manifesto by Atul Gawande
What is Leadership: with David Marquet
David Marquet, Former-Captain, US Navy Seals: Turn The Ship Around!
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22: Role of Culture and Behaviors in Leading Hi-Performing Teams and Delivering Enhanced Performance
In this episode, Nuala Calnan chats with Matt Pearson, VP of Quality System & Risk Management at Guardant Health, about how to “switch on” your organisation to proactively manage risk and continuously improve your processes by focusing on creating a culture, where mindsets, behaviors and employee engagement deliver real performance improvement for the business. Matt explains his views on achieving a quality culture, how to strive for workplace engagement, how an organization's structure can lead to fractures, and the three critical enablers for anyone planning to implement sustainable culture change within their organization.
SHOW NOTES:
ISPE Cultural Excellence Report (2017) https://guidance-docs.ispe.org/doi/book/10.1002/9781946964618
Carol Dweck Mindset book: https://www.amazon.com/Mindset-Psychology-Carol-S-Dweck/dp/0345472322
Access Shane Craddock’s materials: https://shanecradock.com/
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18: Quality Business Leadership
This month on Risk Revolution, Lori Richter chats with Anders Vinther, PhD, the Founder & CEO of Quality Business Administration (QBA). Lori and Anders discuss sustained product quality, consistent product supply, and robust financial performance. Anders shares the Six Traits of a QBL. Anders also shares his thoughts on preserving quality as a company value and the role of engagement in delivering this competitive business advantage.
This month’s show notes include:
Learn more about the QBA program: https://qbaleaders.com/
QBA program feedback from participants: https://qbaleaders.com/qbl-program-feedback/
Want to apply to be in a cohort? https://qbaleaders.com/certification-program-application-form/
Taking a Stand for Pharmaceutical Quality: The Rise of the Quality Business Leader
Deming Institute: https://deming.org/the-deming-philosophy/
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18: Happy Birthday QRM!
The Risk Revolution Crew is back with an exciting celebratory podcast. Join Nuala, Val, and Lori as they reflect on 20 years of QRM with Prof Kevin O’Donnell. This week’s guest needs almost no introduction to our listeners as he was the rapporteur for the ICH Q9(R1) update, chairs the PIC/s expert circle on QRM and is the Market Compliance Manager with the Irish Regulatory Agency the HPRA. Prof O’Donnell shares his reflections on the QRM journey and what is to come.
Listeners should note that Prof O’Donnell’s views are his own and do not necessarily reflect those of the agencies and organizations referenced above.
Show Notes
ICH Q9(R1) and the supporting training materials can be accessed here:
https://www.ich.org/page/quality-guidelines
The EMA recommendations draw on lessons learned from the presence of nitrosamines in sartan medicines
https://www.ema.europa.eu/en/news/european-regulators-make-recommendations-drawing-lessons-learnt-presence-nitrosamines-sartan-medicines
Technical Report No. TR 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages
https://www.pda.org/bookstore/product-detail/7852-technical-report-no-68
Welcome to Risk Revolution! The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.
The hosts for this series are Nuala Calnan, Valerie Mulholland, and Lori Richter.
Ireland