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Job Description
Senior Quality Assurance Manager - Clinical Operations & Product Release at RevereIT LLC Senior Quality Assurance Manager - Clinical Operations & Product Release at RevereIT LLC in Hamden, Connecticut Posted in about 11 hours ago.
Type:
full-time
Job Description:
Job Description:
We are seeking an experienced Senior Quality Assurance Manager with strong expertise in pharmaceutical/biopharmaceutical quality systems to lead clinical finished product release and distribution activities. The ideal candidate will have extensive experience in GxP-regulated environments, quality investigations, supplier quality oversight, and Veeva Vault QA approval processes. This role requires strong leadership, analytical skills, and the ability to drive continuous improvement while collaborating across cross-functional teams. Key Skills (12pt) Clinical Finished Product Release & Distribution GxP Quality Assurance & Compliance Veeva Vault (QA Approver Experience) Deviations, Investigations & CAPA Management Supplier Quality & CMO Oversight (Packaging & Labeling) Audit & Inspection Readiness Required Qualifications (12pt) 8+ years of experience in Pharmaceutical/Biopharmaceutical Quality Assurance Strong experience working in GxP-regulated environments Hands-on experience with Veeva Vault as a QA Approver Solid background in investigations, CAPA, and supplier quality management Experience supporting clinical product quality and distribution activities Additional Skills (12pt) Quality Metrics, KPI Monitoring & Data-Driven Reporting Continuous Improvement Initiatives Risk-Based Decision Making Strong Analytical and Problem-Solving Skills Cross-Functional Leadership and Collaboration