Alonza Cruse
FDA - Office of Inspections & Investigations - Director, Office of Human & Animal Drug Inspectorate. (Retired)
- Role
- Director, Office of Pharmaceutical Quality Operations at FDA
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
Experience
Director, Office of Pharmaceutical Quality Operations
Oct 2015 — Present · Silver Springs, MD, US
The Office of Pharmaceutical Quality Operations (OPQO) coordinates domestic and foreign inspectional, quality and investigational activities across the field and at headquarters. In addition, OPQO works closely with the Center for Drug Evaluation & Research (CDER) and the Center for Veterinary Medicine (CVM) on compliance and enforcement activities and to implement policies related to the Pharmaceutical program such as the Food & Drug Administration Safety & Innovation Act (FDASIA), Drug Quality & Safety Act (DQSA), Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Act (GDUFA).
Education
The City University of New York
B.S.
1980 — 1986
Skills
- Gmp
- Regulatory Affairs
- Pharmaceutical Industry
- Sop
- Fda
- Policy
- Regulatory Submissions
- Leadership
- Life Sciences
- Biotechnology
- Management
- Government
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