Computer System Assurance Expert

Job Summary

Managing the execution of Computer System Assurance (CSA) projects, the full-time remote Computer System Assurance Expert will ensure compliance with global regulations and internal quality standards while leading teams to create validation packages that support technology solutions.

Key responsibilities

• Develop and execute risk-based validation plans for computer system projects in alignment with CSA methodology and regulatory expectations
• Manage the creation and review of validation lifecycle documentation, including Validation Plans and Test Plans
• Lead day-to-day validation testing execution, coordinating with project teams and ensuring adherence to protocols

Required qualifications

• Bachelor's or Master's Degree in Life Sciences, Engineering, Computer Science, Information Systems, or related fields
• 5+ years of experience in a validation role managing GxP computer systems in a biopharmaceutical or medical device company
• 5+ years of experience authoring and executing validation deliverables for complex systems
• Experience leading project teams or managing validation specialists is a plus
• Knowledge of the system development lifecycle (SDLC) and project management principles