Director of Global Inspection Readiness & Compliance

Posted yesterday

celldexHampton (NJ)

Regulatory Affairs Managers Pharmaceutical Preparation Manufacturing

SENIORITY

Manager

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About the role

Celldex in New Jersey is seeking a Director to serve as the primary architect and leader of the inspection management program, ensuring readiness for FDA inspections, partner audits, and commercial launch activities. The role collaborates across Quality, Manufacturing, Regulatory Affairs, Clinical Development, and Commercial functions to build a sustainable readiness framework, manage Health Authority responses and CAPAs, and drive continuous improvement through the product lifecycle.

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