Director, Head of Japan Quality, Quality Business Partner for Commercial, Distribution and the Countries

This is what you will do:

This position is the main Quality contact in Japan and will have strong experience in GxP’s, GQP and Quality Management Systems (QMS) and will have worked in an global Quality environment. This role will lead the implementation and execution of the local and Enterprise Quality System (SOP’s and Technology) and support compliance to current regulations, procedures and standards across the business.

They will be a key commercial business partner for Japan and the General Manager and will collaborate cross functionally for new product launches, changes in the QMS and lead cross functional collaboration.

They will have suitable qualifications and experience to act as the Soseki in order to provide strong representation and leadership to the General Manager and the Japan Alexion Management Team.

They will lead local the Quality team to ensure product and/or service is consistent and meets the requirements and established standards. This includes performing and managing tasks associated with GQP for production and quality control and GMP for investigational new drug for developing items.

Lead and have experience in Quality discussions with Regulators _ Tokyo Health Authority, PMDA etc. as required.

You will be responsible for:

• Ensure on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards at the site level.
• Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with local guidelines.
• Act as Soseki to ensure Quality and Safety issues are reviewed, escalated and guidance provided to the General Manager
• Provide internal auditing resource to assess site compliance on a regular basis
• Manage the review and implementation of Quality Improvement/remediation plans for site identified through Corporate, internal or Health Authority nspections
• Support local/regional Quality activities
• Monitor GMP, GQP and GDP compliance to local regulations and Alexion’s procedures
• Partner with local, regional and global operational groups to foster a proactive approach to compliance.
• Create partnerships with Japanese contractors and work with the global team to manage and monitor performance
• Ensuring that the quality management system (QMS) is maintained and assist in the implementation of Enterprise processes and includes but not limited to;
• Deviation
• Corrective Action Preventative Action (CAPA)
• Complaint Management
• Change Control
• Documentation
• Training
• Recall
• Self-Inspection
• Quality Risk Management
• Quality Management Review
• Ensure that accurate quality records are maintained in support of Data Integrity
• Ensure appropriate local QMS training is implemented and tracked across the organisation
• Maintain quality agreements with suppliers/distributor/wholesaler and Alexion global.

• Support the Japanese Regulatory Affairs function with the;

• Clinical products import,
• Submission of GMP documents to PMDA, including, but not limited to;

– PMDA GMP clearances and

– GMP inspection applications on a PCA

• Assist in the coordination of recalls, registration and processing of customer complaints, reconciliation.
• Work closely with Supply Chain, Regulatory affairs, PV to ensure compliance and support for the business.

You will need to have:

• 10+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
• Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
• Registered Pharmacist is preferred for the role of Marketing Supervisor-general (Soseki)
• Thorough knowledge of CMC science such as the process validation, QC testing and so on
• Good knowledge of government regulations and guidelines (local, EMA, FDA, PMDA) pertaining to GXP and Pharmacovigilance required
• Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
• Exceptional communication and interpersonal skills to cultivate the good relation with the business partners such as CMO, analytical labs and so on.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.