Tara Greene has 25 years of combined FDA and industry experience in quality and regulatory matters. Her expertise spans regulatory arenas from small molecule to parenteral and biotechnology drug products and encompasses markets from CDMOs, API, and fill/finish to clinical development and commercial manufacturing.
Ms. Greene joined the US FDA and built a respected reputation during her six years as a Pharmaceutical Inspectorate and Drug Specialist with the Kansas City District Office. She conducted complex small molecule, radiopharma, and biologics inspections and now utilizes this experience to advance compliance with the FD&C Act to ensure public safety with novel drug products.
Ms. Greene served as the Director of Quality Assurance with Gallus Biopharmaceuticals and later as Site Director of Quality for Patheon Biologics. In both roles she maintained oversite for the firm's St. Louis, MO and Princeton, NJ facilities. Ms. Greene reorganized the quality departments and built a competent, loyal staff of over one-hundred direct and indirect quality, regulatory and quality control personnel.