Quallyna Porte is a Branch Chief (Acting), in the Office of Manufacturing Quality in CDER’s Office of Compliance leading a team responsible for regulatory oversight of the human drug manufacturing industry.
Prior to joining the FDA, Quallyna worked in the pharmaceutical and biotech industries for 18 years. She worked at Baxter Healthcare Corporation (Bioscience Division – Vaccines) in various roles of increasing responsibilities starting with Quality Control up to Facility Quality Management Representative. In the latter role, Quallyna oversaw the commercial manufacturing and release of vaccine products to various geographies, and finally the transfer of technology overseas. She also led the Quality Assurance organization at Emergent BioSolutions in the establishment of Quality Systems at a new facility, qualification of said facility, and subsequent cGMP manufacturing of Phase I to III clinical products.
Quallyna is a Six Sigma Green belt who received her BS in Biology from Saint Paul’s College and an MBA from the University of Maryland, University College.