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Senior Director, Quality

Repligen Corporation
September 02, 2026
Full-time
Remote friendly (Waltham, MA)
Worldwide
Operations
Role: Senior Director, Quality overseeing global Filtration & System networks, ensuring compliance, quality standards, and continuous improvement. Responsibilities include leading quality strategy, managing Quality Assurance, Quality Systems, Validation, supplier quality, customer audits, and regulatory interactions; developing and maintaining robust quality management systems; driving customer satisfaction and operational excellence; and mentoring a high-performing quality organization. Requirements: Bachelor's in Science, Engineering, or related; 15+ years in quality leadership within bioprocessing, biotech, or pharma industries; 5+ years managing quality teams; extensive experience with ISO 9001, GMP, and regulatory audits; strong leadership and stakeholder management skills. Preferred: Knowledge of ISO 13485, sterilization, and bioprocessing technologies. High-value specifics: Focus on bioprocessing, biologics, and regulated manufacturing; global quality oversight; experience with sterilization and sterility assurance programs. Collaboration: Partners with Operations, Commercial, Product Management, Supply Chain, Regulatory Affairs, and senior leaders. Work setup: Opportunity for Waltham, MA or Breda, Netherlands; no explicit travel expectations mentioned.