Michie (Mei Kuen) Ong Gilead Sciences

Michie serves as the leader of the Product Quality Lead (PQL) team at Gilead Sciences, bringing over 20 years of experience in the research, biotechnology and pharmaceutical sectors. Her career spans a broad spectrum of quality disciplines, including regulatory compliance, internal and external audits, global health authority inspections, supplier and contract manufacturing oversight, GMP interpretation, and lean manufacturing integration. Her most recent experience included oversight of multi-product manufacturing facility in cell and gene therapy drug products, where aseptic processing plays a critical role. Most notably, Michie led the successful pre-licensure inspections for a first-in-class cell therapy product, resulting in regulatory approvals from both the U.S. FDA and EMA.