Executive Director, Quality CDMO Management
Listed on 2026-09-14
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Quality Assurance - QA/QC
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Healthcare
Data Scientist
Role:
Executive Director, Quality CDMO Management, overseeing quality operations across Celldex's global external manufacturing network.
Developing strategies for quality oversight of commercial CDMOs in the U.S. and Europe, managing vendor relationships, facilitating cross-functional collaboration, ensuring compliance with GxP regulations, leading quality events, providing performance metrics, building a team of quality leaders, with on-site oversight as needed.
RequirementsBS in a scientific discipline; extensive experience managing CDMO/CMO quality functions, particularly in biologics manufacturing; strong knowledge of FDA, EMA, ICH, and GMP/GxP standards; proven track record in supplier quality, audits, and regulatory inspections.
Preferred qualificationsAdvanced degree and leadership in quality systems, deviations, CAPA, and change control.
High-ValueBiologics manufacturing, GxP compliance, global regulatory standards, cross-functional vendor management, and quality leadership at senior level.
Work Setupon-site presence required; location not specified.
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