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 qualified — 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 document

📌 Csv (Computer Systems Validation) Manager (Pune)
🏢 TransPerfect
📍 Pune