Quality Assurance and Regulatory Guidance

Dr. Stuart Irwin offers over a decade of experience leading Quality Assurance functions in early-phase biologics. He has successfully built and scaled quality systems that support rapid clinical progression, with core strengths in developing standard operating procedures (SOPs), validating equipment and monitoring systems, and managing deviations, investigations, and CAPAs. His work is consistently aligned with executive goals to ensure quality and compliance are integrated into the organization's growth strategy.

Dr. Irwin’s interdisciplinary background—spanning immunology, microbiology, and applied business analytics—positions him to bridge scientific rigor with operational efficiency. He specializes in implementing practical metrics and real-time dashboards that support decision-making at all levels. His approach emphasizes timely follow-up, process accountability, and measurable outcomes to drive continuous improvement in fast-paced, regulated environments.