【Alexion Japan】 Associate Director, Japan Country Quality

About this role

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 Approver of all GMP documents requiring Quality approval including Investigations, Change Controls, Validation Documents, Specifications, Complaints, Master Batch Record Provide support and acts as point of contact during regulatory health inspections as needed and lead inspection readiness activities in collaboration with other functional groups Ensure inspection readiness for GXP-impacting activities in the Commercial organization; work with cross-functional colleagues to analyze risks and develop inspection readiness strategy Product support in the technical aspects of project and manufacturing transfer (overseas sites / Japan), process improvement action, the validation planning and implementation improve the quality of surface and manufacturing process Monitor GXP, GDP and Pharmacovigilance compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality Ensure the products are produced, tested, and released in compliance with SOPs, cGMPs and local regulations such as

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