Head of CSV – Switzerland

BioTalent is partnered with a leading biologics organisation to support the hire of a Head of CSV, with expertise across GxP computer system validation in regulated manufacturing environments.

This role will offer you

• Strategic leadership of CSV activities across manufacturing sites
• Influence over digital compliance during a major growth phase
• A key role in inspection readiness and regulatory compliance
• A collaborative, quality-driven company culture

Key Responsibilities:

• Define and implement the global CSV strategy across manufacturing and QC systems
• Ensure compliance with GAMP 5, EU Annex 11, and 21 CFR Part 11
• Partner with QA, IT, and regulatory teams to support audits and inspections

Key Requirements:

• Proven CSV experience in GMP environments, ideally in biologics/CDMO settings
• Strong understanding of relevant regulations and validation frameworks
• Experience managing cross-site or global CSV programmes
• Excellent stakeholder management and communication skills