Captain Qiao Bobo serves as a Division Director in FDA’s Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ). She oversees the assessment of manufacturing processes, microbiology, and facilities for small-molecule drugs and biologics, supporting regulatory submissions including INDs, NDAs, ANDAs, BLAs, and supplements.
Dr. Bobo has over 28 years of combined FDA and pharmaceutical industry experience. Since joining FDA in 2010, she has held progressively senior scientific and leadership positions in both CBER and CDER, focusing on pharmaceutical manufacturing, microbiology and facility assessments. She is a certified lead inspector with extensive domestic and international pharmaceutical manufacturing inspection experience. She has also led inspection training and workforce development initiatives and represented FDA in international regulatory forums, including PIC/S and ICH.
Prior to joining FDA, Dr. Bobo spent 12 years in the pharmaceutical and biotechnology industries, from startups to large pharmaceutical companies, gaining experience in regulatory affairs, manufacturing, testing, and inspection preparedness for drugs, biologics, and medical devices. She holds a Ph.D. in Cell and Molecular Biology from the University of Vermont.
