Operational Area Quality Senior Manager

Key Duties and Responsibilities

• Lead Quality Assurance support for assembly manufacturing operations of medical device and combination products, ensuring compliance with GMP, regulatory requirements, and internal quality systems.
• Provide quality oversight for product disposition activities, including review and approval of manufacturing documentation to support timely release of clinical and commercial product.
• Review and approve Manufacturing Batch Records (MBRs), Electronic Batch Records (EBRs), Device History Records (DHRs), and associated manufacturing documentation.
• Lead and approve manufacturing deviations, investigations, nonconforming material reports (NCMRs), CAPAs, change controls, and effectiveness checks.
• Conduct and lead root cause investigations using structured problem-solving methodologies and ensure implementation of effective corrective and preventive actions.
• Support manufacturing operations by providing real-time quality oversight for assembly processes, equipment issues, process improvements, and manufacturing investigations.
• Partner with Contract Manufacturing Organizations (CMOs) to ensure compliance with Quality Agreements, disposition requirements, manufacturing investigations, and continuous improvement initiatives.
• Support manufacturing process validation, equipment qualification, technology transfers, and process improvements to ensure products remain in a validated state.
• Lead supplier quality activities including supplier investigations, supplier change assessments, supplier qualification, and quality issue resolution.
• Support regulatory inspections, customer audits, supplier audits, and internal audits while ensuring timely responses and closure of observations.
• Support complaint investigations and product quality assessments as required.
• Support Design Quality activities by reviewing design changes, participating in design reviews, supporting Design History File maintenance, and ensuring manufacturing changes are appropriately evaluated through design controls and risk management.
• Provide input into risk management activities, including DFMEA, PFMEA, hazard analyses, and Risk Management Files, to ensure manufacturing risks are appropriately evaluated throughout the product lifecycle.
• Promote continuous improvement initiatives to enhance manufacturing quality, compliance, operational efficiency, and product reliability.

Knowledge and Skills

• Strong experience supporting assembly manufacturing operations for medical devices and combination products.
• Demonstrated experience reviewing and approving MBRs, EBRs, DHRs, product disposition, manufacturing investigations, CAPAs, deviations, change controls, and nonconforming material records.
• Strong knowledge of autoinjector and drug-device combination products, including assembly processes, manufacturing operations, supplier management, and product lifecycle support.
• Demonstrated knowledge of GMP, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable combination product regulations.
• Experience supporting process validation, equipment qualification, technology transfers, and manufacturing readiness.
• Experience working with Contract Manufacturing Organizations (CMOs) and external suppliers.
• Working knowledge of Design Controls and Risk Management to support manufacturing quality activities and lifecycle changes.
• Strong technical problem-solving, investigation, and root cause analysis skills.
• Excellent leadership, communication, and cross-functional collaboration skills.
• Experience with statistical analysis tools, Minitab, and quality engineering methodologies preferred.

Education and Experience

Bachelor’s degree in Engineering, Life Sciences, Quality, Manufacturing, or a related technical discipline is required. Advanced degree preferred. Typically requires 10+ years of Quality Assurance, Quality Engineering, Manufacturing Quality, or Operations Quality experience within the medical device, biotechnology, pharmaceutical, or combination product industry. Minimum of 5 years supporting GMP manufacturing operations, including assembly manufacturing, product disposition, deviation management, investigations, CAPA, change control, and batch record review. Demonstrated experience supporting autoinjector, prefilled syringe, or other drug-device combination products from clinical through commercial manufacturing. Experience leading cross-functional quality initiatives and partnering with Contract Manufacturing Organizations (CMOs) and suppliers. Prior people leadership or demonstrated technical leadership of complex quality programs is preferred.