Quality Assurance and Regulatory Guidance

Dr. Stuart Irwin brings over a decade of leadership in Quality Assurance, with a proven track record of designing, implementing, and advancing comprehensive quality systems tailored for early-phase biologics. His expertise spans SOP and workflow development, equipment monitoring and validation, risk assessments, and robust management of deviations, investigations, and CAPAs—all seamlessly coordinated with executive leadership to drive organizational alignment.

With a broad interdisciplinary foundation forged in high-growth environments, Dr. Irwin combines advanced academic training in medicine (specializing in immunology and microbiology) and business (with a focus on biostatistics). As a change management and key performance indicator specialist, he prioritizes actionable, real-world metrics, real-time dashboard solutions, and immediate follow-up to maintain operational excellence.