CSV (Computer Systems Validation) Manager

About the role

The CSV (Computer Systems Validation) Manager will lead TransPerfect’s global Life Sciences compliance initiatives for the Trial Interactive platform. Reporting to senior leadership, the role combines regulatory expertise, technical authority, and people management to ensure all computerized systems meet 21 CFR Part 11, GCP/ICH, and ISO 9001 QMS standards.

Key responsibilities

• Direct validation activities across the full Software Development Life Cycle, including COTS systems, third‑party vendor qualification, and IT infrastructure validation.
• Draft, review and approve validation deliverables such as plans, risk assessments, traceability matrices, test protocols and summary reports.
• Conduct regulatory compliance assessments (e.g., 21 CFR Part 11, EU Annex 11) and operational readiness reviews.
• Manage change control, periodic review and ongoing maintenance of validated systems, ensuring audit‑ready documentation.
• Lead investigations of validation incidents, root‑cause analyses, CAPA implementation and client escalation reporting.
• Serve as the primary subject‑matter expert during client audits, regulatory inspections and internal quality reviews.
• Supervise a team of 2–3 CSV professionals, fostering a culture of quality and continuous improvement.

Required profile

• Extensive experience in Life Sciences or regulated IT environments, with proven knowledge of 21 CFR Part 11, GCP/ICH and ISO 9001 QMS.
• Strong technical writing ability and mastery of English communication.
• Demonstrated leadership skills, capable of guiding a small validation team.
• Ability to translate regulatory requirements into actionable validation strategies.

Required skills

• Risk‑based validation methodology
• Software Development Life Cycle (SDLC) governance
• Commercial off‑the‑shelf (COTS) system qualification
• IT compliance testing, including disaster recovery and vulnerability management