Jennifer Maguire PhD

Deputy Director, Office of Quality Surveillance, CDER/FDA

Dr. Jennifer Maguire is the Director of the Office of Quality Surveillance/OPQ/CDER/FDA. The office assesses intelligence throughout the drug product lifecycle to inform stakeholders about the state of pharmaceutical quality and uses data analytics to drive surveillance decisions. During her tenure at the agency, 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, Quality Metrics and Quality Management Maturity. Prior to joining the agency in 2010, she worked in industry on the development and scale-up of drug substance manufacturing processes and the manufacturing of drug product clinical and stability supplies. Dr. Maguire has a BS in Chemical Engineering from the University of Virginia and a PhD in Industrial and Physical Pharmacy from Purdue University.