Senior Specialist Quality Assurance, CSV
Remotedxb
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.
#J-18808-LjbffrVacancy posted 2 days ago
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