Senior Specialist Quality Assurance, CSV

Responsibilities

• Partner cross-functionally with IT and the business to implement and maintain compliant computerized systems
• Provide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards
• Serve as the QA CSV SME during vendor evaluations, software implementation and qualification and requalification of GxP systems
• Support continuous improvement of GxP Systems through SOP development, training, and change control management
• Lead investigations for CSV-related deviations, system failures, and data integrity issues
• Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports
• Perform internal audits to ensure systems are maintained in a steady state
• Support validation and QA oversight of AI/ML-enabled GxP systems

Requirements

• 7+ years experience in pharmaceutical/biotech space
• 5+ years experience with CSV validation lifecycle management
• Bachelor’s degree in a life science field
• Understanding of 21 CFR Part 11/Annex 11, CSA, IT SDLC, GDPR, and GAMP 5
• Experience with SaaS/PaaS GxP systems validation
• Experience validating or assessing AI/ML-based systems in a regulated environment

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match
• Flexible time off
• Generous parental leave

About the Company

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric and neurological disorders using scientific rigor.