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Head Quality Assurance – 80-100%

Ophtapharm AG
1 day ago
Full-time
On-site
Zürich, ZH

JobsCloseBy Editorial Insights

Ophtapharm AG seeks a strategic yet hands on Head of Quality Assurance to lead QA at sterile ophthalmic site near Winterthur, ensuring GMP, FDA and Swissmedic compliance and driving quality across the organization. You will oversee deviations, CAPAs and risk management, interface with regulatory authorities, clients and teams, and drive quality improvements in an environment. Requires a degree in life sciences, 7+ years in QA within sterile pharma, strong GMP and 21 CFR Swissmedic knowledge, leadership experience, and fluency in English and German. To apply, tailor your CV to highlight regulatory success, CAPA leadership and measurable improvements, cite audits and risk decisions, and note Hettlingen 80-100%.

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.