- Paris, Île-de-France, France
- Senior
- 6–8 years
Computer System Validation (CSV) Manager to act as the quality gatekeeper for IT systems supporting R&D activities, ensuring all computerized systems are fully compliant with regulatory requirements and internal quality standards.
Responsibilities
- Define and lead the CSV strategy for R&D IT systems, ensuring compliance with global regulations (GxP, FDA, etc.)
- Act as the guarantor of system validation and compliance, ensuring all systems are audit-ready at all times
- Oversee the full validation lifecycle (URS, FS/DS, IQ/OQ/PQ, documentation, periodic reviews)
- Ensure high-quality validation documentation, aligned with regulatory expectations and internal standards
- Lead audit and inspection readiness, acting as a key contact for internal and external audits