Job Description
Role Summary
Sr Manager, CSV on the Computer System Validations IT team. Based in San Diego, reporting to the Director, CSV you’ll engage on CSV projects as a key team member and provide guidance to ensure computerized systems are deployed following lifecycle management and remain in a validated state per SOPs, regulatory and security requirements.
Responsibilities- Develop risk-based validation strategies for system implementation and changes following CSV SOPs and Work Instructions
- Coordinate all validation activities with outsourced validation vendor when managing cloud applications
- Manage and provide oversight on multiple projects simultaneously
- Coordinate and lead validation activities with internal stakeholders and project team members
- Author CSV documents (Validation Plans and Summary Reports)
- Ensure training requirements are complete for project team members (CSV SOP, Test Execution, Gdoc, etc.)
- P...
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