Jennifer Maguire, PhD

Dr. Jennifer Maguire is the Director of the Office of Quality Surveillance/OPQ/CDER/FDA. The office strives to be the global benchmark for pharmaceutical quality surveillance. Its mission is to turn quality intelligence throughout the product lifecycle into insights and actions to promote the availability of quality medicines for the American public. Dr. Maguire began her tenure at the Agency in the Office of Generic Drugs as a Chemistry Assessor before joining the newly created Office of Pharmaceutical Quality to focus on process and facility aspects of drug applications. During her tenure, Dr. Maguire has contributed to multiple initiatives aimed at advancing the regulation of pharmaceutical manufacturing and product quality including Question-based Review, Quality by Design, ICH Q12, Site Selection Model Program, Advanced Manufacturing, Quality Metrics and Quality Management Maturity. She also represents the agency on the PIC/S Committee of Officials and is engaged in multiple efforts focused on global harmonization. Dr. Maguire has a BS in Chemical Engineering from the University of Virginia and a PhD in Industrial and Physical Pharmacy from Purdue University.