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【Alexion Japan】 Associate Director, Japan Country Quality

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Alexion Pharmaceuticals
📍 Japan, Japan
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Location Japan
📅
Posted June 26, 2026
🚗
Commute Local Area
🎯
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Job Description

Principal Responsibilities

  • Partner and collaborate with leads and colleagues to ensure the roll out and on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards to the JP organization.
  • Provide leadership and resource management support to the technical transfer to local CMO and/or the analytical laboratory for the incoming test in Japan.
  • Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with global and local GDP, GXP and PV guidelines.
  • To overview, support and provide guidance for manufacturing plants, local and overseas, so that they can perform appropriate manufacturing and quality control, in accordance to the current GQP Ministerial Ordinance
  • Represent Quality in the CMC team of projects and provide input into CMC planning, coordination, and decision making to provide technology transfer and validation support
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    📍 Location Details

    🌆
    City
    Japan
    🗺️
    Country
    Japan
    🚗
    Commute
    Local Area

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