Director / Sr Director Quality Assurance (GxP) - Needham
1 month ago

Job summary
We are seeking a seasoned quality systems professional to lead our GxP systems across QA, Clinical Ops, CMC and Research.- Manage the end-to-end lifecycle of GxP systems ensuring full compliance with 21 CFR Part 11 and modern industry standards.
- Lead qualification risk assessment and ongoing oversight of vendors including eQMS EDMS training systems supply chain tools cloud-based clinical applications.
- Own all CSV activities including SOP development vendor questionnaires test scripts reports periodic reviews revalidations maintain inspection-readiness at all times.
Job description
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