Senior Specialist, Quality Assurance, CSV

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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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