CSV & GxP Compliance Lead

About the role

We are looking for an experienced Computer System Validation (CSV) and GxP Compliance Lead to drive validation activities for our technology platforms, applications, and services. The role works closely with IT, Quality, Development and Business teams to ensure all regulated systems meet industry and regulatory standards.

Key responsibilities

• Lead CSV activities across GxP‑regulated systems and applications.
• Ensure software, cloud platforms and infrastructure comply with GAMP 5 and 21 CFR Part 11.
• Develop and maintain validation documentation such as VMPs, URS, functional specs, risk assessments, IQ/OQ/PQ protocols, reports and traceability matrices.
• Collaborate with cross‑functional teams to define validation scope and strategy.
• Support audits and inspections by providing evidence of compliance.
• Perform periodic reviews, re‑validations and change‑control assessments.
• Provide training and guidance on CSV best practices.
• Maintain awareness of evolving regulations and data‑integrity principles.

Required profile

• Minimum 10 years of CSV experience in regulated industries (life sciences, pharma, healthcare).
• Deep knowledge of GxP, GAMP 5, 21 CFR Part 11 and data‑integrity concepts.
• Proven ability to lead validation projects from planning to closure.
• Strong technical writing and documentation skills.
• Experience supporting FDA, EMA or similar audits.
• Excellent communication, collaboration and project‑management abilities.

Required skills

• GxP
• GAMP 5
• 21 CFR Part 11
• Computer System Validation (CSV)
• LIMS
• ERP
• eQMS
• AWS
• Azure
• SaaS platforms