Validation CSV Expert (Pharma)

TL;DR

Validation CSV Expert (Pharma): Leading the computer system validation strategy for R&D and Medical IT systems with an accent on GxP compliance, audit readiness, and regulatory alignment. Focus on managing the full validation lifecycle, overseeing change control processes, and ensuring high-quality documentation for critical digital solutions.

Location: Paris, France

Company

hirify.global is a global biopharmaceutical company focused on transformative medicines in oncology, rare disease, and neuroscience, dedicated to creating real impact for patients worldwide.

What you will do

• Define and lead the CSV strategy for R&D IT systems to ensure global regulatory compliance.
• Oversee the full validation lifecycle including URS, FS/DS, and IQ/OQ/PQ documentation.
• Act as the primary contact for internal and external audits and inspection readiness.
• Manage change control processes and assess validation impacts for system evolutions.
• Collaborate with IT, Quality, Regulatory, and business stakeholders to ensure system alignment.
• Support project teams in embedding validation requirements into system implementations.

Requirements

• 6–8 years of experience in Computer System Validation within the pharmaceutical or life sciences industry.
• Strong knowledge of regulatory frameworks including GxP, FDA 21 CFR Part 11, Annex 11, and GAMP5.
• Proven experience managing validation lifecycles and audit/inspection processes.
• Experience working with R&D systems such as Veeva, LIMS, or ELN.
• Fluent in English.
• High level of rigor in documentation and compliance practices.

Culture & Benefits

• Strategic role at the intersection of innovation and regulatory compliance.
• Exposure to international, cross-functional environments.
• Commitment to human-centric leadership and inclusive workplace culture.
• Focus on excellence and patient impact.