Zhihao Qiu, PhD
FDA/CDER/OPQ/OPF
Director (Acting), Office of Pharmaceutical Manufacturing Assessment
Dr. Qiu is an Acting Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER, FDA.<br/>
Prior to his current position, he was an acting Division Director in the Division of Microbiology Assessment and a Branch Chief in the Division of Inspectional Assessment, Office of Process and Facilities, CDER. He joined CDER as Branch Chief in the Biotech Manufacturing Assessment Branch in the Office of Compliance, where he managed the microbiology review and pre-license inspection program for CDER regulated BLAs. 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.<br/>
Dr. Qiu obtained his Ph.D. degree in Biological Sciences from the University of Southern California.
Prior to his current position, he was an acting Division Director in the Division of Microbiology Assessment and a Branch Chief in the Division of Inspectional Assessment, Office of Process and Facilities, CDER. He joined CDER as Branch Chief in the Biotech Manufacturing Assessment Branch in the Office of Compliance, where he managed the microbiology review and pre-license inspection program for CDER regulated BLAs. 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.<br/>
Dr. Qiu obtained his Ph.D. degree in Biological Sciences from the University of Southern California.