Quality Assurance and Regulatory Guidance

Dr. Irwin has over ten years of Quality Assurance leadership, and has installed, operated and evolved several complete quality systems for early phase biologics: SOP and workflow development, equipment monitoring and validation, risk assessments, deviation/investigation/CAPA management with regular coordination with executive team. Broad interdisciplinary background developed in high growth conditions. Graduate degrees in both medicine (immunology and microbiology) and business with specialization in biostatistics. Change management and key performance indicator specialist, with preference for real-world metrics, real-time dashboard management and immediate followup.