In this episode of The QP Diaries, we’re joined by Stephen Clarke, newly appointed Head of Quality and Qualified Person at BDD. With decades of experience across diverse pharmaceutical environments and a proven track record leading global Quality functions, Stephen shares his unique journey, from his early days in food lab QC to becoming a QP responsible for complex clinical and commercial products. Stephen reflects on the formative years of his QP training, the value of cross-site exposure in sterile and OSD manufacturing, and the realities of batch certification in today’s evolving regulatory landscape. Now at BDD, he’s leveraging his deep GMP expertise to support cutting-edge radiolabelled medicines and same-day QP release, accelerating clinical insights and patient access. We explore the growing responsibility of QPs in shaping Pharmaceutical Quality Systems (PQS), the impact of AI on decision-making, and why strong communication is critical when working in contract manufacturing. Stephen also shares how he mentors the next generation of Quality professionals and the one piece of advice he’d give to his younger self. Whether you're a trainee QP, Quality leader, or simply curious about the human side of pharmaceutical compliance, this episode is packed with practical insights and leadership perspective.

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