Senior Specialist, Quality Assurance, CSV

September 5, 2026

Job Description:

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
Partner with IT and Business teams to ensure SDLC and validation requirements are clearly defined and met
Lead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysis
Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports
Advise on data integrity best practices and approaches
Partner with IT to ensure inspection readiness is maintained for CSV
Serve as QA reviewer for all new system releases and change controls
Perform internal audits to ensure systems are maintained in a steady state and user management is under control
Ensure adherence to regulatory and quality standards throughout the software development lifecycle
Support systems and new product introduction by providing QA expertise, problem solving, and strategies for risk mitigation
Support validation and QA oversight of AI/ML-enabled GxP systems, including risk assessment for model changes and ongoing performance monitoring

Requirements:

7+ years experience working in the pharmaceutical/biotech space required
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

Benefits:

100% paid health benefits including Medical, Dental and Vision for you and your dependents
401(k) program with company match and vesting after the turn of the first month after your start date
Flexible time off
Generous parental leave and some fun fringe perks!

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