Global QA Compliance Expert
Provide technical leadership for global Supply Chain in delegated Good Distribution Practice (GDP) related matters, as well as Quality Assurance expertise during preparation and negotiations of supply and commercial agreements, and to prepare and negotiate global quality agreements for warehousing, distribution and international transport with internal and external partners.
- Ensure that all aspects of handling and distribution of pharmaceutical products (including record management) comply with GMP/GDP, Corporate Quality Manual and with the regulatory and legislative requirements;
- Ensure continuous improvement of quality relevant processes within delegated area of responsibility;
- Support defining supply chain QA strategy to ensure compliance of Swiss Hub and all department’s sites and country organizations with all aspects of GDP (e.g. deviation handling, transport monitoring, return of goods and recall management);
- Provide high standard and on-time quality expertise during preparation and negotiations of supply and commercial agreements to ensure correctly designed and implementable quality related processes;
- Prepare and negotiate global quality agreements for warehousing, distribution and international transport with internal and external partners;
- Support self-inspections and prepare/support Health Authority inspections (e.g. FDA, Swissmedic, EMA).
Qualifications and Experience:
- University degree in life sciences, preferably in pharmacy or chemistry or equivalent;
- Minimum 12 years of experience in the pharmaceutical industry from which 8 years were in a managing quality role;
- Extensive knowledge and experience in leading global teams;
- Experience in communication with manufacturing sites and market authorization holders;
- Experience in communication with international project teams;
- Fluent in English (spoken and written) and preferably German;
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required.