Senior Specialist Quality Assurance, CSV
$101,147–$122,757 year
RemoteUnited States or New York, United States
Job Summary
Partner cross-functionally with IT and business teams to implement and maintain compliant computerized systems, ensuring adherence to GxP standards, GAMP 5, and 21 CFR Part 11. Provide quality oversight for the lifecycle of computerized systems by establishing policies, reviewing validation documentation, and approving system releases and change controls. Lead investigations for deviations and data integrity issues, including root cause analysis, while performing internal audits to maintain steady-state system control. Support continuous improvement through SOP development, training, and risk mitigation strategies for new product introductions and AI/ML-enabled GxP systems. Serve as the QA CSV SME during vendor evaluations and qualification processes to ensure inspection readiness.
Required Qualifications
- 7+ years experience working in the pharmaceutical/biotech space
- 5+ years' experience with CSV validation lifecycle management
- Bachelor's degree in a life science field
- Excellent understanding of 21 CFR Part 11/Annex 11 compliance and Computer System Validation (CSV), Computer System Assurance (CSA), IT SLDC best practices, General Data Protection Regulation (GDPR) regulations, and GAMP 5 Guidance
- Proven experience in assisting validation efforts for SaaS/PaaS GxP systems
- Broad understanding of Technology implementation (SaaS) and Data migrations approaches
- Experience validating or assessing AI/ML-based systems in a regulated environment, including understanding of model risk and change control considerations
- Demonstrated experience in reviewing key validation deliverables such as user requirements, validation plans, validation reports and test scripts
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