Brian Trdina MS AstraZeneca

Brian Trdina is the Director for Emerging Technology at AstraZeneca’s Global Audit Team, with 30+ years in drug and biologics manufacturing and quality. He leads the integration of new modalities and new technology into AstraZeneca’s GxP auditing standards and competencies, ensuring that the team’s technical acumen and training remain current as innovation advances. From 2018 to 2024, Brian served as Global Quality Audit Regulatory Inspection and Surveillance Director, where he translated enforcement trends and evolving expectations from EMA, FDA, PIC/S, and ICH into AstraZeneca’s Quality Management System. His audit experience spans biologics, vaccines, cell therapy, APIs, oral solids, and combination products, focusing on GMP compliance, supplier oversight, and lifecycle validation consistent with current enforcement priorities. Earlier at MedImmune, he led the manufacturing quality and disposition team supporting commercial mAb manufacturing, served as the quality lead for the qualification and licensure of a large-scale mammalian bioreactor facility, and directed supplier management and auditing for direct materials, GMP services, and external testing labs. Brian holds a BS in Chemistry (Indiana University of Pennsylvania) and an MS in Quality Assurance and Regulatory Affairs (Temple University).