Tara Gooen Bizjak

At Johns Hopkins, Tara Gooen Bizjak is a lecturer in the MS in Regulatory Science program.

A Captain in the United States Public Health Service Commissioned Corps, she has worked in the areas of drug manufacturing, current good manufacturing practice inspections, and related policy for the U.S. Food and Drug Administration since 2002. Gooen Bizjak is currently an Associate Director, GMP and Quality Standards in the Office of Compliance within the Office of Manufacturing Quality at the Center for Drug Evaluation and Research.

Prior to her current role at USFDA, she was a senior science policy advisor in the Office of Pharmaceutical Quality. She also served as branch chief for drug manufacturing pre-approval inspection compliance, a senior advisor in the Office of Inspections and Investigation’s Office of Policy and Risk Management, and a field investigator for drug manufacturers. She has held two American Society for Quality certifications as a Certified Quality Engineer and a Certified Quality Improvement Associate.

Gooen Bizjak earned a BS in Chemical Engineering from Cornell University and an MS in Biomedical Science from Rutgers University, with concentrations in stem cell biology and biodefense. She resides in Rockville, Maryland with her husband, daughters, and pup and enjoys traveling and reading.