Job Description
Ophtapharm AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmic products). At our production site in Hettlingen near Winterthur, high-quality products such as eye drops, ointments, and gels are aseptically produced, filled, and packaged for international markets.
Head Quality Assurance – 80-100%
You lead and develop the Quality Assurance function for a sterile manufacturing site producing ophthalmic products. You ensure regulatory compliance (FDA, Swissmedic) and drive quality performance across the organization.
We are looking for a strategic and hands-on leader to take on the role of Head Quality Assurance (80–100%) at our site near Winterthur.
Your Role
- Lead and develop the Quality Assurance function, ensuring compliant and efficient site operations
- Ensure compliance with GMP, FDA, and Swissmedic requirements across all quality processes
- Oversee deviations, CAPAs, and risk management to ensure product quality and patient safety
- Act as key interface to regulatory authorities, clients, and cross-functional teams
- Drive continuous improvement of quality systems, processes, and performance
Your Profile
- Degree in Pharmacy, Chemistry, Microbiology, or a related life sciences field
- 7+ years’ experience in Quality Assurance within sterile pharmaceutical manufacturing
- Strong knowledge of GMP, FDA (21 CFR), Swissmedic, and international regulatory requirements
- Proven leadership experience in managing QA teams in regulated environments
- Fluent in English and German
What you can expect
- High-impact leadership role with full responsibility for Quality Assurance at site level
- Direct exposure to regulatory authorities, audits, and inspections
- Real influence on quality systems, performance, and organizational development
- Lean organization with fast decision-making and visible impact
For recruitment agencies:Thank you for your interest. We are not engaging external support for this role.
Do you have any questions?Our HR team in Hettlingen is happy to assist you. Tel: +41 52 304 13 23.
