Mary Malarkey

FDA/CBER/OCBQ

Director, Office of Compliance and Biologics Quality

Mary Malarkey – Director, Office of Compliance and Biologics Quality (OCBQ), at FDA’s Center for Biologics Evaluation and Research (CBER). Her previous management positions at CBER were Director, Division of Case Management from 2000-2005 and Branch Chief in the Division of Manufacturing and Product Quality (DMPQ) from 1996-2000. Ms. Malarkey received her Bachelor of Science in Microbiology from the University of Maryland, College Park, in 1981. She worked in Research and Development in industry prior to joining FDA, and has been with CBER since 1989. She did laboratory work in both the Office of Therapeutics Research and Review and Office of Blood Research and Review prior to becoming a full time regulatory reviewer in 1993.