Quality Assurance Manager (Switzerland & Austria)

About the role

Recordati is looking for an experienced Quality Assurance Manager responsible for the Swiss (CH) and Austrian (AT) markets. You will ensure compliance with legal, regulatory and GMP/GDP requirements, manage central QA processes and act as the main liaison with authorities, service providers and partners.

Key responsibilities

• Maintain and develop the Quality Management System in line with country‑specific legislation, GMP/GDP and regulatory standards.
• Create, review and approve SOPs and other quality‑related documents, including Management Review reports.
• Initiate and handle Change Controls, Deviations, CAPAs, complaints, returns and OOS/OOT cases.
• Conduct self‑inspections and serve as the reference person during authority inspections.
• Qualify, evaluate and monitor suppliers and service providers, perform audits and maintain Quality Agreements.
• Organise GXP‑relevant training for staff and monitor training compliance.
• Assume country‑specific QA responsibilities: market authorisation for CH (FvP) and batch release for AT (fachkundige Person).

Required profile

• University degree in Natural Sciences, Pharmacy, Medicine, Engineering or a comparable qualification.
• 5–8 years of QA/GDP experience in the pharmaceutical industry.
• Strong knowledge of regulatory requirements in Switzerland and Austria.
• Familiarity with authorities such as Swissmedic and BASG is a plus.
• Structured, independent and solution‑oriented working style with a passion for international collaboration.

Required skills

• SAP
• Veeva