FDA
Division Director
Dr. Maotang Zhou is a Division Director in the Office of Pharmaceutical Quality Assessment III (OPQAIII), OPQ, CDER, FDA. He joined the FDA in 2008 as a CMC reviewer. Since then, he has amassed extensive experience in leading and performing quality assessments for both new and generic drug applications. During his tenure at the FDA, Dr. Zhou significantly contributes to the development of guidances, policies, and Manuals for Policies and procedures (MaPPs) by serving on various working groups and technical committees at CDER. Prior to joining FDA, Dr. Zhou spent over 12 years in the pharmaceutical industry including serving as the R&D Vice President at Chiral Quest and working at BMS and Pfizer/Wyeth in developing API manufacturing processes. He was instrumental in transferring several API manufacturing processes to commercial facilities in Ireland and Puerto Rico.