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Director Office of Compliance and Biologics Quality

Food and Drug Administration

Silver Spring, Maryland$204k – $282kToday

About the role

The Director for the Office of Compliance and Biologics Quality (OCBQ) ensures biologics distributed in the U.S. meet standards for purity, potency, and effectiveness, and are manufactured and distributed in accordance with Agency guidelines. Represents the Center Director on regulatory and product quality matters, providing executive leadership to four Divisions handling case management, inspections, and surveillance of biologics manufacturing and quality regulated by CBER. Monitors the quality control of marketed biological products through surveillance, inspections, report evaluation and compliance programs, and coordinates testing of marketed products with other components of FDA. Coordinates with Agency components to identify and recommend actions based on surveillance and evaluation of advertising and clinical experience reports from manufacturers and sponsors of CBER-regulated products. Develops policies and procedures; reviews and acts on establishment license applications (exc

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