Manager, Computer System Validation (CSV), QA

Role Summary

Manager, Computer System Validation (CSV), QA will provide quality oversight of the computer system validation lifecycle for GxP applications, ensuring compliance across design, implementation, and retirement of systems. This role requires expertise in CSV/CSA, strong quality systems acumen, and cross-functional collaboration to maintain validated states for platforms such as Veeva, Argus, SAP, and Tracelink in compliance with FDA, EMA, ICH, GAMP 5, and related requirements.

Responsibilities

• Provide QA oversight of the GxP computer system validation lifecycle, ensuring ongoing compliance and validated state through design, configuration, updates, and maintenance
• Review and approve IT change control and validation deliverables, including protocols, test scripts, and reports of the GxP validated system
• Evaluate risk assessments and determine the impact of changes/updates on user experience, system performance, and compliance
• Participate, review, and approve periodic system reviews and release management activities, identifying and remediating compliance gaps
• Collaborate with IT, cross-functional stakeholders such as business owners, to establish and enforce requirements for system validation, data integrity, and ongoing system maintenance
• Drive continuous improvement initiatives for QMS and validated GxP systems
• Support regulatory inspections and audits, ensuring adherence to 21 CFR Part 11, EU Annex 11, GxP, and other regulatory frameworks
• Support inspection remediation activities and CAPA management through timely resolution and closure
• Collaborate with cross-functional teams to optimize workflows, reporting capabilities, and system usability for business and compliance needs
• Review and approve GxP-computer system SOPs, and support end-user training to ensure proper adoption and compliance
• Serve as QA CSV subject matter expert (SME) and provide guidance on risk-based validation strategies (CSV/CSA)

Qualifications

• Bachelor‚Äôs or Master‚Äôs degree in software, computer engineering, or technical field
• 8+ years of experience in quality systems development and maintenance within clinical and commercial-stage pharmaceutical or biotech companies
• Excellent attention to detail and strong organizational skills
• Effective communication skills both written and verbal
• Demonstrated expertise in GxP computerized system validation (CSV/CSA) and system lifecycle management
• Strong working knowledge of regulatory requirements, including: 21 CFR Part 11, EU Annex 11, ICH Q10, GAMP 5
• Hands-on experience with computer system validated platforms (Veeva eTMF, Quality, QMS, RIM; SAP; Argus; Tracelink)
• Experience developing GxP SOPs and training personnel on compliance requirements
• Ability to work independently and collaboratively within a team
• Ability to influence and drive cross-functional teams
• Familiarity with risk-based validation methodologies (CSV/CSA)