Executive Director, Commercial Quality Systems

Role: Executive Director, Commercial Quality Systems, leading the design, development, and continuous enhancement of Celldex's global Quality Management System (QMS) to support commercial and late-stage clinical products. Responsibilities: oversee key quality processes including deviations, CAPA, change control, complaint management, document control, training, and inspection readiness; manage and develop a team of four quality leaders across Quality Management, Inspection, and Medical Devices; develop and implement electronic QMS systems and inspection management strategies; partner cross-functionally with Regulatory, Manufacturing, Supply Chain, IT, and Operations; monitor quality metrics, drive strategic initiatives, and manage departmental budgets. Qualifications: BS in a scientific discipline with advanced degree preferred; extensive experience supporting commercial biologics, product lifecycle quality, and enterprise QMS; strong knowledge of FDA, EMA, ICH, and GxP regulations; proven experience with audit readiness, inspections, deviations, CAPA, and quality systems management; prior success leading high-performing quality teams. High-Value: focus on biologics and commercial product lifecycle, global regulatory compliance, electronic QMS platforms, inspection management, and cross-functional collaboration. WorkSetup: not specified; salary range $233,631–$303,417.