Senior Quality Assurance Specialist

Job Summary

To ensure compliance with regulatory and quality standards, the remote Senior Quality Assurance Specialist will manage GxP systems implementation, validation, and maintenance while collaborating with IT and business teams on system lifecycle activities.

Key responsibilities:

• Partner cross-functionally to implement and maintain compliant computerized systems
• Provide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5 and 21 CFR Part 11
• Lead investigations for CSV-related deviations and serve as the QA lead for system releases and change controls

Required qualifications:

• 7+ years of experience in the pharmaceutical/biotech industry
• 5+ years of experience with CSV validation lifecycle management
• Bachelor's degree in a life science field
• Strong understanding of 21 CFR Part 11 compliance and GAMP 5 Guidance
• Experience validating AI/ML-based systems in a regulated environment