Senior Manager, Operational Area Quality; Combination Products

General Summary

• Provide quality leadership for assembly manufacturing operations supporting medical device and combination products, including quality oversight of manufacturing, product disposition, batch record review, deviations, investigations, CAPAs, change controls, supplier quality, and regulatory compliance; partner cross-functionally and support design quality and risk management alignment.

• Lead Quality Assurance support for assembly manufacturing (GMP and internal quality systems).
• Oversee product disposition; review/approve manufacturing documentation for timely release.
• Review/approve MBRs, EBRs, DHRs, and related manufacturing documentation.
• Lead/approve deviations, investigations, NCMRs, CAPAs, change controls, and effectiveness checks.
• Conduct root-cause investigations and ensure corrective/preventive actions are effective.
• Provide real-time quality oversight for assembly processes, equipment issues, and manufacturing investigations.
• Partner with CMOs on Quality Agreements, disposition, investigations, and continuous improvement.
• Support process validation, equipment qualification, technology transfers, and improvements.
• Lead supplier quality activities (investigations, change assessments, qualification, resolution).
• Support regulatory/customer/supplier/internal audits and complaint investigations.
• Support design quality: evaluate design changes through design controls and risk management (e.g., Design History File).
• Contribute to risk management (DFMEA/PFMEA/hazard analyses/Risk Management Files) and drive continuous improvement.

• BS in Engineering/Life Sciences/Quality/Manufacturing or related; MS/advanced degree preferred.
• 10+ years in Quality/Manufacturing Quality/Operations Quality (medical device/biotech/pharma/combination products); 5+ years specifically supporting GMP assembly manufacturing (disposition, deviations, investigations, CAPA, change control, batch record review).
• Demonstrated experience with autoinjector/prefilled syringe or similar drug-device combination products.
• Knowledge of GMP and 21 CFR 820/4; ISO 13485/14971; design controls and risk management.
• Strong problem-solving/root-cause skills; leadership and cross-functional collaboration.
• Preferred:
  Minitab/statistical tools and people leadership.

• Pay range: $133,800–$200,600; eligible for annual bonus and annual equity; benefits include medical/dental/vision, paid time off (company shutdown), educational assistance/student loan repayment, commuting subsidy, matching donations, and 401(k).