Senior Specialist, Quality Assurance, CSV
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!
