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