CSVValidationLead

**Job Description:** **DXC Technology** (NYSE: DXC) helps global companies run their mission-critical systems and operations while modernizing IT, optimizing data architectures, and ensuring security and scalability across public, private, and hybrid clouds. The world’s largest companies and public sector organizations trust DXC to deploy services across the Enterprise Technology Stack to drive new performance levels, competitiveness, and customer experience. Learn more about how we deliver excellence for our customers and colleagues at DXC.com. **_CSV Validation Lead_** The **CSV Validation Lead** is responsible for overseeing the lifecycle validation of computer systems to ensure compliance with global regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11). This role provides strategic leadership in developing validation frameworks, managing risk-based testing strategies, and ensuring that all IT systems—from lab equipment to enterprise ERPs—are fit for their intended use and maintain data integrity. **_Requirements_** * GxP Mastery: Expert knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. * Experience: 7+ years in CSV, with at least 2 years in a leadership or coordination capacity within a regulated industry. * System Knowledge: Experience validating platforms such as SAP S/4HANA, LIMS, QMS (TrackWise/Veeva), MES, or clinical trial systems. * Cloud Compliance: Understanding of validating SaaS/Cloud solutions and managing the shared responsibility model * Attention to Detail: An uncompromising eye for documentation quality and "audit-ready" evidence. * Risk Management: Ability to apply ICH Q9 principles to scale validation efforts effectively (don't over-validate low-risk items). * Communication: Ability to negotiate between IT (who want speed) and QA (who want compliance). **_Key Responsibilities_** * Validation Strategy: Develop and maintain the Validation Master Plan (VMP). Define the scope of validation efforts using a risk-based appro