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
Please apply/email your resume with your availability to [email protected] to have a confidential discussion about this opportunity.
BioTalent Ltd are acting as an employment agency in relation to this opportunity.