Qualified Person (QP) / Responsible Person (FvP) (60-100%)

• 16 July 2026 • 60 - 100% • Indefinite duration • Hettlingen CH Ophtapharm AG is an FDA/EU-GMP certified pharmaceutical manufacturer specializing in ophthalmic products. At our production site in Hettlingen near Winterthur, we aseptically manufacture, fill and package high-quality products such as eye drops, ointments and gels for international markets. Qualified Person (QP) / Responsible Person (FvP) (60-100%) # As a Qualified Person (FvP), you are responsible for providing leadership and supervision of quality compliance matters within the business entity in support of the quality system. By law, the Qualified Person is directly responsible for the technical supervision of operations, ensuring the safety, efficacy and quality of medicines.   We are looking for a pragmatic and influential professional as a Qualified Person (QP) / Responsible Person (FvP) (60-100%), to be filled immediately or by mutual agreement. Your role • Act as Qualified Person (QP) / Responsible Person (FvP) in accordance with Swiss regulatory requirements (HMG, AMBV) and the Swissmedic technical interpretation I-SMI.TI.17. • Ensure compliance with applicable GMP requirements and regulatory commitments across all manufacturing operations. • Evaluate critical quality issues and support decision-making regarding product quality, compliance and patient safety. • Serve as the primary contact for Swissmedic and represent the company during regulatory inspections and audits. • Act as an independent quality authority and trusted partner, balancing compliance, quality and business needs. Your profile • Master's or PhD in pharmacy, chemistry, biology or a related scientific discipline. • Eligible to act as Qualified Person (QP) / Responsible Person (FvP) according to Swiss regulatory requirements, with the professional qualifications and experience required for Swissmedic recognition. • Minimum 5 to 7 years of experience in sterile pharmaceutical manufacturing in a GMP regulated environment. • Strong expertise in GMP and regulatory requirements, with sound judgment on critical quality issues and a good understanding of manufacturing processes and customer requirements. • Credible communicator with an independent, pragmatic and solution-oriented mindset; proficiency in English and German, both written and spoken. What you can expect • A highly visible role with direct influence on product quality, compliance and critical decisions for the company. • The opportunity to leave your mark in a company undergoing transformation and to actively shape its future quality organization. • Broad responsibilities and close collaboration with key stakeholders in the company. • Short decision-making paths, pragmatic solutions and the ability to have a tangible impact. • An attractive pension scheme, free parking and convenient access by public transport.   For recruitment agencies: Thank you for your interest. We are not seeking external support for this position. You have questions? Our HR team is happy to help you. Tel: +41 52 304 13 23