The Senior Manager, Quality Assurance (Med Device / Combination Products) will be responsible for ensuring compliance with quality standards for pharmaceuticals, medical devices, and combination products. This role involves implementing integrated quality systems that meet federal and international regulations.
Key Responsibilities:
- Ensure compliance with quality standards by implementing phase-appropriate integrated quality systems for pharmaceuticals, medical devices, and combination products.
- Implement continuous improvement throughout R&D and Commercial Operations, and conduct Management Reviews, focusing on Key Performance Indicators that support Quality Management Reviews.
- Lead or participate in quality investigations, including the generation and follow-up of metrics for the overarching QMS, including Issue/Deviation, Corrective and Preventive Action (CAPA), Supplier Corrective Action Requests (SCAR), and Change Control.
- Oversee the effectiveness of production processes, specifications, and test methods in conjunction with Quality Control/product disposition.
- Supervise quality compliance activities related to the development and implementation of policies, procedures, training, controls, measurements, corrective/preventive action, and audits (GCP, GMP, QSR, and ISO 13485:2016).
- Oversee quality compliance activities related to the review of quality records, including Clinical Study Reports, Trial Master Files, Device History Records, Deviations, OOS reports, audit reports, Research and Development protocols and reports, and Software validation protocols and reports.
- Conduct audits of GCP, GLP, and GMP suppliers and service providers, including CAPA assessment and follow-up.
- Manage activities for registration readiness by interpreting regulations and developing procedures for ISO, CE marking, and other international requirements, including readiness of vendors, suppliers, CMOs, and laboratories.
- Oversee change controls, complaints, investigations, CAPAs, IQ/OQ/PQ protocols and reports, specifications, and stability protocols to ensure compliance with regulatory requirements (FDA/ICH/ISO).
- Review and approve lot analytical methods, method validation protocols and reports, and stability protocols.
- Conduct final product lot and clinical trial supplies disposition activities, ensuring compliance with cGMPs, company SOPs, policies, and specifications.
This role requires a seasoned professional with a proven track record in quality assurance for medical devices and combination products, capable of managing complex quality systems and driving continuous improvement. The ideal candidate will have extensive experience in quality compliance, regulatory requirements, and leading quality investigations.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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