Senior Manager, Operational Area Quality (Combination Products)

Role: Lead quality oversight for assembly manufacturing of medical device and combination products, ensuring GMP compliance, regulatory adherence, and product quality. Responsibilities: review and approve manufacturing documentation, lead investigations, deviations, CAPAs, change controls, and supplier quality activities; support process validation, equipment qualification, and lifecycle management; collaborate with CMOs and internal teams on quality improvements and audits; support design quality and risk management activities. Qualifications: Bachelor's in Engineering, Life Sciences, or related; 10+ years in Quality Assurance or Manufacturing Quality within the medical device or biopharma industry; 5+ years supporting GMP manufacturing, particularly for autoinjectors and drug-device combos; strong knowledge of GMP, 21 CFR Part 820/4, ISO 13485, ISO 14971; proven experience with manufacturing processes, investigations, supplier management, and lifecycle activities. HighValue: medical device and combination products, autoinjectors, clinical-to-commercial manufacturing, GMP, regulatory inspections, design controls, risk management tools. WorkSetup: hybrid or on-site, flexible scheduling.