Senior Manager, GxP IT Quality Assurance & E-Compliance
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About The Position
Senior Manager, GxP IT Quality Assurance & E-Compliance, Bristol-Myers Squibb Company, New Brunswick, NJ. Oversee computer system validation and software development to assure regulatory compliance across the end-to-end product lifecycle (Research & Development). Ensure the research and development is conformance to current GxPs, guidance documents, applicable industry accepted standards and requirements. Review and approve the key computer software life cycle (SLC) deliverables. Oversee key software development life cycle (SDLC) process such as problem, incident, change, release, etc. Ensure adequate and timely regulatory compliance support. Report on key metrics across the ITQA tower. Oversee the qualification BMS infrastructure that support regulated business applications. Support on regulated system Data Migrations, Data Archival and Retirements. Provide active support during regulatory agency and third-party inspections. Research new technologies, understand existing processes, and reference recognized standards and frameworks. Recruit, manage and coach beeline contractors and third-party vendors on BMS Computer System Validation (CSV) procedures to support computer system validation and software development.
