Senior Specialist Quality Assurance, CSV

The Senior Specialist Quality Assurance, CSV role is responsible for ensuring GxP systems are implemented, validated, and maintained in compliance with regulatory and quality standards. This role partners closely with IT and business teams to support system lifecycle activities, including vendor evaluations, software implementation, and system qualification and requalification. 

 

The QA CSV SME drives risk-based validation processes by establishing and refining policies, procedures, and work instructions, while ensuring Software Development Lifecycle (SDLC) and validation requirements are clearly defined and consistently met. This position reviews and approves validation documentation, provides guidance on data integrity best practices, and serves as the QA lead for system releases and change controls. 

 

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 

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 

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.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. 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!