Mary Manibusan OQS, CDER, FDA

Mary Manibusan is a Supervisory Operations Research Analyst in FDA's Office of Quality Surveillance, where she leads the Pharmaceutical Quality System Assessment Program, providing risk-based assessments, strategic policy analyses, and scientific leadership. She also coordinates teams responsible for statistical consulting and natural hazards surveillance for drug manufacturing firms.

With over two decades of federal regulatory experience spanning FDA and EPA, Mary has a distinguished career in scientific human health risk assessment, policy development and regulatory management. She also represented the United States as the technical lead on the first harmonized multinational pesticide risk assessment, earning the Distinguished Senior Fellows Award from the Council of Excellence in Government.

Mary holds a Master of Public Health in Toxicology from the University of Michigan and a Bachelor of Arts in Biological Sciences from the University of California, Santa Barbara.