Qiao Bobo PhD

Division Director, Office of Product Quality, CDER/FDA

Dr. Qiao Bobo joined FDA in 2010, and currently serves as a Commander (CDR) in the United States Public Health Service (USPHS) and as a Division Director in the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). She oversees the scientific review and quality evaluation of pharmaceutical manufacturing of sterile drugs. Prior to joining CDER, CDR Bobo served as a Branch Chief in the Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER), FDA, where she oversaw pre-license and pre-approval inspections and manufacturing assessment of vaccines, therapeutics and devices regulated by CBER. She also served as a reviewer, lead inspector and team lead. Prior to joining the FDA, CDR Bobo spent 12 years in the private sector, from small startup company to big pharma, drafting regulatory submissions, auditing CMOs, and ensuring CGMP compliance for drugs, vaccines, cell and gene therapy products and devices. She is the recipient of numerous awards, including a Meritorious Service Medal, AMSUS Rising Star, Senior Scientist of the Year, FDA Admirals’ Mentorship Awards, and FDA Commissioner’s Special Citations. CDR Bobo holds a Ph.D. degree in Cell and Molecular Biology from the University of Vermont.