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Senior Director, Quality

Repligen Corporation
September 01, 2026
Full-time
Remote friendly (Marlborough, MA)
Worldwide
Operations
Role: Senior Director, Quality β€” responsible for strategic leadership and oversight of Repligen's global Filtration & System networks, ensuring quality, compliance, and customer satisfaction across all sites. Responsibilities include developing and improving Quality Management Systems, maintaining regulatory compliance, managing customer and certification audits, and fostering a culture of quality excellence. Collaborates with Operations, Commercial, Product Management, Supply Chain, Regulatory Affairs, and senior leadership to drive operational performance and continuous improvement. Oversees quality metrics, investigations, compliance initiatives, and builds high-performing teams. Qualifications: Bachelor's in Science, Engineering, or related field; 15+ years in quality leadership within bioprocessing, biotech, pharma, or regulated manufacturing; 5+ years managing quality organizations; 7+ years leading teams; experience with ISO 9001, ISO 13485, GMP, and sterile processing is highly desirable. High-Value: extensive bioprocessing/biotech quality management, global leadership, regulatory audits, sterilization/sterility programs, cross-functional collaboration. Work Setup: based in Waltham, MA, USA or Breda, Netherlands; location options flexible.