Sr. Manager, Computer Systems Validation

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.)