Our customer, a leading international pharmaceutical company with headquarters in Basel, is looking for an experienced QA Compliance Expert / Global SC QA Project Manager In this role of responsibility, you will provide technical leadership for global Supply Chain in delegated Good Distribution Practice (GDP) related matters, to ensure that all aspects of the business comply with legal, regulatory requirements and the Corporate Quality Manual. You will provide high standard Quality Assurance expertise during preparation and negotiations of supply and commercial agreements to ensure correctly designed and implementable quality related processes. Your main tasks:
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.
Maintain current knowledge of regulatory and legislative requirements and trends related to GxP and specifically to GDP to ensure that the expert advice and appropriate technical support on all quality related distribution activities is provided.
Act as subject matter expert for the Supply Chain QA in global/local projects where applicable.
Support defining Supply Chain QA strategy to ensure compliance of Swiss Hub and all Technical Operations 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) in Technical Operations Supply Chain.
Your background: You are a customer oriented person, who builds and maintains close relationships with all business partners. Furthermore, you communicate in a clear, open and timely manner and are able to motivate your Supply Chain members. You set clear priorities and readily assume responsibility. You are detail and quality oriented and have high attention to GMP.
University degree in life sciences, preferably in pharmacy or chemistry or equivalent
Several years of experience in the pharmaceutical industry in a managing quality role
Deep leadership knowledge and experience in GxP, preferably GDP (Good Distribution Practices)
Experience in communication with pharmaceutical manufacturing sites and market authorization holders. Experience in communication with international project teams.
Good understanding of Supply Chain Management (SCM) processes and related business processes (e.g. in DRA, GQA, Technical Operations)
Fluent in English (spoken and written) and preferably good communication skills in German
Assignment start: asap Assignment duration: planned until the end of the year (with a chance for contract prolongation) Workload: 100% (40h/week) Workplace: Basel If you have the required experience and if you would like to apply for this interesting position, please send your complete application documents (CV, testimonials, diplomas) to janine.cabrera(at)kellyservices.ch or apply online. We are looking forward to getting to know you!
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