Senior Specialist Quality Assurance, CSV

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
• Partner with IT and Business teams to ensure SDLC and validation requirements are clearly defined and met
• 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
• Lead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysis
• 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

Pay

The starting base pay range for this position is $101,147.00 - $122,757.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.

Benefits

The Company provides competitive benefits to employees including: 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!