In this episode of NSF’s Compliance Unlocked, we’re joined by Dr. Kay Hukin to explore one of the most critical—and often misunderstood—topics in the pharmaceutical industry: quality management maturity, quality culture, and the role of senior leadership in the pharmaceutical quality system (PQS). Dr. Hukin draws on her experience working with global organizations, regulators, and senior leadership teams to explain why—despite clear regulatory expectations—over half of critical and major inspection findings are still linked to failures in the PQS. Key topics covered in this episode: Why senior management is ultimately accountable for the pharmaceutical quality system (ICH Q10 & EU GMP Chapter 1) What effective leadership really means in the context of quality Why quality must be everyone’s responsibility, not just the quality function How leadership behavior directly shapes quality culture—positively or negatively Common leadership behaviors that undermine quality maturity Practical steps to reset and rebuild quality culture What Quality Management Maturity (QMM) actually means—and why it matters How better quality maturity leads to fewer deviations, improved supply reliability, and better patient outcomes The role of data, KPIs, and avoiding “vanity metrics” How organizations can assess and benchmark QMM across sites and regions Dr. Hukin also explains how small improvements in quality maturity can deliver both economic and public health return on investment, helping organizations reduce waste, improve compliance, and avoid supply disruptions—while getting medicines to patients faster. If you’re a senior leader, quality professional, or executive responsible for compliance, governance, or operational performance, this episode offers clear, practical insights into what regulators expect—and how leadership engagement can make or break quality performance. NSF Life Sciences Companies all over the world rely on NSF’s expert team of pharma biotech, medical device, IVD, and combination product experts to guide them through the maze of regulations and industry challenges. Our experts can tailor a solution to meet the specific needs of your company. Since 1944, NSF has helped companies deliver life-saving and life-changing medical products to their patients. Find out more on NSF.org You can contact our life sciences team by emailing: lifesciences@nsf.org or by visiting: https://www.nsf.org/contact-us Learn more about NSF’s Pharma & Biotech expertise: https://www.nsf.org/life-sciences/pharma-biotech