Celia N. Cruz, PhD

Director, Division of Product Quality Research
Celia Cruz is the Director of the Division of Product Quality Research in the Office of Testing and Research at FDA. Before joining the FDA in 2010, Celia worked in industry for eleven years, where she led teams responsible for the development and commercialization of solid oral drug products. As a black belt in Design for Six Sigma, she was an early adopter of Quality by Design and the use of quality risk assessments for guiding drug product development.

At FDA, Celia’s division is responsible for developing and implementing CDER regulatory research goals on product and process understanding, in support of review, policy and inspections. Celia has served as a product and process reviewer for new and generic drugs, as liaison for Quality by Design, and as a former Lead of the CDER Nanotechnology Working Group. She currently a member of the FDA Emerging Technology Team, focusing on continuous manufacturing applications and has spoken nationally and internationally on the subject.

Celia Cruz has a B.S. and Ph.D. in Chemical Engineering from Brown University and Carnegie Mellon University, respectively.