Qa Compliance Expert / Global Sc Qa Project Manager (f/m)

Year    Basel, BS, Switzerland

Job Description

Job Purpose:
  • 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 and regulatory requirements
  • Provide high standard Quality Assurance 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 on behalf of company
Major Accountabilities:
  • 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.
  • Mantain 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 Novartis Technical Operations (NTO) Supply Chain QA in global/local projects where applicable.
  • Support defining NTO Supply Chain QA strategy to ensure compliance of Swiss Hub and all NTO 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 processe.
  • 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 NTO Supply Chain.
Requirements:
  • University degree in life sciences, preferably in pharmacy or chemistry or equivalent
  • Fluent in English (spoken and written) and preferably German.
  • Minimum 12 years of experience in the pharmaceutical industry out of which 8 years in a managing quality role.
  • Deep leadership knowledge and experience in GxP, preferably GDP (Good Distribution Practices).
  • Extensive knowledge of the products and business processes experience in leading global teams.
  • Experience in communication with manufacturing sites and market authorization holders. Experience in communication with international project teams.
Start: ASAP
Duration: first contract until end of the year
Workload:100%
Location: Basel Are you interested? Please send your complete application over our webpage. 27266

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Job Detail

  • Job Id
    JD12844
  • Industry
    Fertilizers/Pesticides
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Basel, BS, Switzerland
  • Education
    Not mentioned
  • Experience
    Year
  • Apply By
    Mar 06, 2020
  • Job Posting Date
    Dec 07, 2019