Zhihao Qiu, PhD

Director (Acting), Office of Pharmaceutical Manufacturing Assessment
Dr. Qiu is a Branch Chief in the Division of Inspectional Assessment, Office of Process and Facilities, CDER, FDA. The Division oversees the scientific review, pre-approval inspection, and quality evaluation of the manufacturing process and facilities for INDs, NDAs, ANDAs, BLAs, and supplements. Prior to his current position, he was a Branch Chief in the Biotech Manufacturing Assessment Branch in the Office of Compliance in CDER, where he managed the microbiology review and pre-license inspection program for CDER’s Biologics License Applications. Dr. Qiu joined FDA as a facility reviewer and pre-license inspection investigator in the Office of Compliance and Biologic Quality, CBER. He then joined the Center for Devices and Radiological Health (CDRH) as an Associate Director in the Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device Evaluation and Safety. At CDRH, he was responsible for managing pre-market review for Class II and Class III toxicology devices. He also served as the lead compliance officer for the Division’s postmarket program including recalls, EIR reviews, inspections, and warning letters.

Dr. Qiu is an experienced lead investigator and has led many BLA pre-license inspections. He also participated in several NDA and device inspections as a Subject Matter Expert. Dr. Qiu has over 10 years of experience in the biotech and IVD industries, with responsibilities in new technology development, tech transfer, and GMP manufacturing.

Dr. Qiu obtained his Ph.D. degree in Biological Sciences from the University of Southern California.