Computer System Assurance Consultant

Job Summary

A company is looking for a CSA Consultant - Veeva Quality.

Key Responsibilities

• Develop and support CSA deliverables, including CSA plans, risk assessments, test plans, and traceability matrices
• Review vendor-generated validation scripts to ensure compliance and completeness
• Partner cross-functionally with Quality, IT, and business stakeholders to support implementation activities

Required Qualifications

• ~10+ years of experience in GxP-regulated environments (biotech/pharma)
• Strong background in Computer System Assurance (CSA) frameworks and methodologies
• 5+ years of experience supporting Veeva Vault or related solutions
• Deep understanding of validation/CSA deliverables and regulatory expectations
• Experience working cross-functionally across Quality, IT, and business teams