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  1. Office of Global Regulatory Operations and Policy

Alonza Cruse, Director, Office of Pharmaceutical Quality Operations

Alonza Cruse, Director, Office of Pharmaceutical Quality Operations

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 Alonza Cruse

Alonza Cruse is director of the Office of Pharmaceutical Quality Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA).  His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, Mr. Cruse is leading ORA’s pharmaceutical collaboration efforts under our Program Alignment initiative.

From 2013 – 2015, Mr. Cruse served as the acting director of the Office of Medical Products & Tobacco Operations  within ORA, overseeing activities such as implementation of the Generic Drug User Fee Amendments,  of pharmacy compounding, and of the development of a new inspection protocols program.

Prior to that, Mr. Cruse was the director of the Los Angeles District Office, where his responsibilities included providing executive leadership to implement, manage and evaluate FDA's regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist.  He received his Bachelor of Science degree in medical technology from York College (City University of New York).