Director of Regulatory Inspection Readiness

Posted yesterday

celldex therapeuticsHampton (NJ)

Regulatory Affairs Managers Pharmaceutical Preparation Manufacturing

SENIORITY

Manager

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About the role

Celldex Therapeutics, Inc. seeks an experienced Director to lead the inspection management program, ensuring readiness for FDA/ international inspections and partner audits. You will coordinate across Quality, Manufacturing, Supply Chain, Regulatory Affairs, Clinical Development, and Commercial functions to support a transition to commercial readiness. The role requires a strong background in GMP compliance, regulatory inspections, and CAPA management, with global CMOs experience preferred.

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