Région Zurich, Switzerland • On-site • Long-term Contract • Level: Senior (5+ years) • English required

Assignment via a specialist pharma/biotech consulting firm. Full administrative support and mission follow-up included.

**Context**
A global pharmaceutical leader is scaling up its site in the Zurich region as part of a major investment programme — one of the most ambitious GMP site transformations in Europe right now.

The site is undergoing large-scale projects including GMP upgrade (EU Annex 1), laboratory revamping, new clinical batch production capacities, and a greenfield facility build. An experienced Compliance Engineer is sought to embed within the Quality function and drive GMP compliance across production and project activities.

A rare opportunity to join a high-impact quality team at the heart of a multi-year industrial transformation — with real scope and ownership.

**Key Responsibilities**

- Ensure GMP compliance of production activities and ongoing capital projects
- Support and lead internal and external audits; prepare for regulatory inspections (FDA, Swissmedic, EMA)
- Author, review and update quality documentation: SOPs, protocols, validation reports
- Guide cross-functional project teams in integrating regulatory requirements (EU Annex 1, FDA, ICH)
- Manage deviations, CAPAs and change controls in a complex, multi-project environment
- Collaborate closely with Production, Engineering and QA departments
- Contribute to the continuous improvement of the Quality Management System

**Your Profile**
Required:

- Scientific degree — pharmacy, chemistry, biology or engineering
- 5+ years of hands-on experience in compliance / quality assurance within a GMP pharma or biotech environment
- Strong knowledge of GMP frameworks: EU Annex 1, FDA 21 CFR, ICH guidelines
- Solid experience managing deviations, CAPAs and change controls
- Fluent English — mandatory

Strong assets:

- German appreciated — facilitates daily interactions on site
- Comfortable working across multiple simultaneous projects — autonomous and solution-oriented

**What's Offered**

- Landmark-scale site transformation programme — rare scope and long-term visibility
- Long-term contract with strong extension potential — this site transformation runs over several years
- International and innovative working environment — cross-functional teams, global standards
- Diverse, high-impact projects: greenfield build, GMP revamping, clinical batch scale-up
- A rare chance to shape quality systems from the ground up on a major industrial site
- Confidential process — response guaranteed within 48 hours

Fabrice Cattant Founder of Recrutis – Expert & Executive Search