CSV (Computer Systems Validation) Manager

OVERVIEW

The CSV (Computer Systems Validation) Manager, Trial Interactive leads and advances TransPerfect's global Life Sciences compliance initiatives, including 21 CFR Part 11, GCP/ICH requirements, and the company's ISO 9001-certified Quality Management System (QMS). The role holds direct accountability for the validation, governance, and continuous improvement of computerized systems using a risk-based approach, ensuring that Trial Interactive platform solutions and related processes meet the highest standards of regulatory compliance, client quality expectations, and internal QMS requirements.

Operating at the intersection of technical authority, regulatory strategy, and people leadership, the CSV Manager drives the maturity and scalability of the CSV function within the Trial Interactive division and provides senior-level support to other TransPerfect divisions as required. The role demands a consummate professional — one who brings mastery-level command of the English language, exceptional technical writing ability, and the executive presence to represent the organization with credibility and precision in any regulatory or client-facing context. The CSV Manager directly leads a team of 2–3 CSV professionals, setting the standard for quality, accountability, and continuous improvement across all validation activities.

DESCRIPTION:

• Lead and govern validation activities across the full Software Development Life Cycle (SDLC), including the validation of commercial off-the-shelf (COTS) systems, qualification of third-party vendors, and oversight of IT compliance activities such as infrastructure qualification, disaster recovery testing, backup and restore testing, and vulnerability management
• Direct the drafting, review, and final approval of all validation deliverables (including validation plans and strategies, requirement specifications, risk assessments, traceability matrices, test protocols and scripts, and validation summary reports) ensuring documentation is complete, precise, and fully compliant with applicable regulations and client quality standards
• Lead regulatory compliance assessments (e.g., 21 CFR Part 11, EU Annex 11), operational readiness reviews, and system release validation activities, translating findings into clear, actionable outcomes across QA, IT, development, and client-facing teams
• Govern change control processes and manage the periodic reviews and ongoing validation maintenance activities, ensuring timely execution, rigorous impact assessments, and audit-ready reporting
• Lead investigations into validation-related incidents, deviations, and system issues; direct root cause analyses, CAPA activities, and client escalation reporting, ensuring all outcomes are thorough, defensible, and resolved within established timelines
• Serving as the primary subject matter expert (SME) and point of escalation during client audits, regulatory inspections, and internal quality reviews
• Directly manage, mentor, and develop a team of CSV professionals, providing structured guidance, meaningful performance feedback, and clear pathways for professional growth
• Drive process improvement initiatives within the Trial Interactive division, including contributions to SOP development, work instruction updates, and QMS enhancement programs
• Complete all other tasks deemed appropriate for this role and assigned by senior leadership.