Head Quality Assurance – 80-100%

Description du poste

Join Ophtapharm AG, an FDA/EU-GMP certified manufacturer of ophthalmic products. This role offers a strategic opportunity in a dynamic work environment. Tasks Lead Quality Assurance for sterile ophthalmic manufacturing operations. Ensure compliance with FDA, Swissmedic, and GMP regulations. Drive continuous improvement in quality systems and performance. Skills Degree in Pharmacy, Chemistry, or related life sciences; 7+ years in QA. Strong knowledge of GMP and regulatory requirements. Proven experience in managing QA teams in regulated settings. About the job 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. 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.