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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