Besins Healthcare
CSV Manager
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Context
Besins Healthcare is a fast-paced, fast-growing, international pharmaceutical company (~1,800 employees, €800M€ revenue) entering a critical phase of enterprise-wide transformation.
The organization is transitioning from a traditional IT operating model toward a product-driven, cloud-enabled, and data-centric environment, while operating within a highly regulated framework (GxP, data integrity, privacy, and global compliance).
As technology becomes increasingly critical to research, manufacturing, quality, supply chain, finance, and commercial operations, ensuring compliance with global regulatory requirements becomes both more complex and more strategic.
To support this ambition, we are seeking an experienced Computer System Validation (CSV) Manager to establish and lead a modern validation function capable of enabling innovation while maintaining compliance.
Role Mission
The CSV Manager is accountable for defining, governing, and continuously improving the company's global Computer System Validation framework.
The role ensures that regulated systems throughout the technology landscape are validated in accordance with applicable GxP, regulatory, data integrity, and company quality requirements.
Beyond compliance, the CSV Manager is expected to modernize validation practices to support:
- Agile delivery
- Product operating models
- Cloud platforms
- SaaS applications
- Data platforms
- Artificial Intelligence solutions
- Automated business processes
The mission is clear: Enable innovation at speed while maintaining inspection readiness and compliance by design.
To achieve this ambition, the CSV Manager will build and lead a high-performing validation organization. The role will also act as a coach and advisor across the organization.
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This role offers the opportunity to redefine how validation is performed within a modern pharmaceutical company. The CSV Manager will not simply manage validation activities. They will shape the future of compliance across Digital products, Enterprise platforms, Data ecosystems, AI solutions, and Cloud technologies.
This is a highly visible leadership role with significant influence on the company's digital transformation journey and long-term success.
Key Responsibilities
- Develop and maintain a modern validation strategy aligned with the company's digital transformation roadmap.
- Build a scalable validation capability supporting future business growth.
- Build and lead a high-performing global CSV team, including talent development, governance, and partner management.
- Ensure validation becomes integrated into product delivery rather than occurring as a late-stage approval process (integrate CSV into product teams, establish validation-by-design principles, support Agile validation methodologies…), as the organization is moving from project-based delivery toward product-centric development.
- Ensure regulated computerized systems remain compliant throughout their lifecycle and are ready for internal/customer audits or regulatory inspections.
- Simplify compliance while maintaining regulatory robustness. Validation efforts should focus on patient safety, product quality, and data integrity.
- Develop modern approaches for validating cloud-based solutions (vendor assessment, supplier qualification, continuous compliance approaches…) to ensure compliance remains practical in modern technology environments.
- Define validation approaches for AI and emerging technologies, to help establish one of the industry's leading approaches to compliant AI adoption.
- Work closely with the Data & AI organization to validate Data Lakehouse platforms, BI and analytics solutions, data integration processes, reporting systems, and data quality controls. A special focus must be placed on data integrity, traceability, auditability, and lineage.
- Ensure continuous inspection readiness and provide leadership during audits, inspections, and regulatory interactions. The role will frequently interact with Quality Assurance, Regulatory Affairs, Internal Audit, External Auditors, and Health Authorities.
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Experience & Profile
Required Experience
- 10+ years in Computer System Validation
- Experience within a regulated pharmaceutical environment
- Experience supporting GxP systems
- Experience interacting with regulatory authorities
- Experience building or leading CSV teams
- Experience supporting digital transformation initiatives
A precedent experience in AI governance/validation methodologies, in data governance programs, agile validation approaches, SaaS validation frameworks, or enterprise architecture collaboration would be highly appreciated.
The ideal candidate combines deep regulatory expertise, strong business pragmatism, technology understanding, leadership capability, and transformation mindset.
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