Sarah Johnson

Sarah Johnson is a Supervisory Regulatory Specialist in the Office of Quality Surveillance (OQS) within CDER/OPQ, where she provides scientific leadership on pharmaceutical quality systems for drug products. She advises on regulatory strategy, risk assessment, and policy development related to drug manufacturing quality and compliance. With over a decade of FDA experience spanning regulatory review, laboratory research, and global inspectional activities, Sarah brings a well-rounded perspective on pharmaceutical quality systems from both scientific and compliance standpoints. She has contributed to the development of international regulatory guidance on manufacturing and served as a subject matter expert on emerging manufacturing technologies. Sarah holds a Ph.D. in Molecular Biology from UCLA and a B.S. in Biology from Randolph-Macon Woman’s College.