R&D CSV Compliance & Validation Lead

Ipsen; Paris; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading pharmaceutical company based in Paris is seeking a Computer System Validation (CSV) Manager to ensure compliance of R&D IT systems with global regulations. This role includes defining CSV strategy and managing the validation lifecycle. Candidates should have 6–8 years of experience in CSV within the pharmaceutical industry, strong knowledge of regulatory frameworks, and excellent stakeholder management skills. Join a collaborative environment focused on ensuring patient safety and compliance.

Qualifications

• 6–8 years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.
• Strong knowledge of regulatory frameworks such as GxP and FDA 21 CFR Part 11.
• Solid experience managing the validation lifecycle and audit/inspection processes.

Responsabilités

• Define and lead the CSV strategy for R&D IT systems, ensuring compliance with global regulations.
• Act as the guarantor of system validation and compliance, ensuring all systems are audit-ready at all times.
• Oversee the full validation lifecycle including documentation and periodic reviews.

Connaissances

Computer System Validation

Regulatory frameworks (GxP, FDA)

Stakeholder management

Documentation rigor

Transversal leadership

Fluent in English

Outils

Veeva

LIMS

ELN

Description du poste

A leading pharmaceutical company based in Paris is seeking a Computer System Validation (CSV) Manager to ensure compliance of R&D IT systems with global regulations. This role includes defining CSV strategy and managing the validation lifecycle. Candidates should have 6–8 years of experience in CSV within the pharmaceutical industry, strong knowledge of regulatory frameworks, and excellent stakeholder management skills. Join a collaborative environment focused on ensuring patient safety and compliance.