品質保証部>Site Compliance and Quality Systems; Associate Director​/部長​/西神工場; 神戸市内

Position: Site Compliance and Quality Systems (Associate) Director/部長/西神工場(神戸市内)
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
** Job Title
** Site Compliance and Quality Systems (Associate) Director
** Department
* * Seishin Quality
** Position Title
** Associate Director / Director
** Supervisor Title
** Site Quality Leader (Sr. Director or above)
** Main Purpose
** This position is responsible for the site quality system and for GMP compliance of the Seishin Manufacturing Site. It ensures that the products manufactured and packaged at the site follow and comply with applicable regulations and GMP requirements, such as Japanese GMP / QMS and global LQS / GQS.The person in this position is also the designed Pharmaceutical Manufacturing Manager(製造管理者) and Manufacturing Manager of Biological-origin

Products(生物由来製品製造管理者) and is the point of contact with the Japanese local authorities.
** Responsibilities
* * The Seishin Site Compliance and Quality Systems Leader is responsible for the following activities:

General requirements
* Provide technical and administrative leadership to the Quality Systems and GMP Compliance team:
Manage team members effectively and develop their capabilities
* Maintain “Well-Being” for team members according to “Red Book” and Lilly HSE policies,
* Ensure that team members are qualified and required trainings are carried out in a timely manner
* Contribute to the Business & Strategy Planning by providing inputs related to Compliance and Quality Systems
* Lead the Site Quality Lead Team Requirements related to the Quality Department
* Develop, ensure implementation and monitor the Site Quality Plan and the Site Self-inspection plan
* Develop, ensure implementation and maintain the Site Quality Policy, Site Quality Manual and Site Master File
* Develop and implement audit and inspection readiness program for the Site.
* Host GMP inspections and audits for Pharmaceutical products, Medical Devices and drug/device combination products
* Establish, implement and maintain site quality system for marketed products, which meet customer expectations, local regulations and global quality standards.
* Establish, implement and maintain GQP/QMSGMP Standards and SOPs according to the requirement of current Pharmaceuticals and Medical Devices Law
* Drive Site Quality Culture initiatives, integrating focus areas such as Data Integrity.
* Make Quality and GMP decisions in a timely manner.
* Participate in global quality and Compliance projects
* Deliver quality improvement projects.
* Maintain good relationship with Heath Care Authorities/ Supplying Sites /CMOs manufacturing on behalf of Lilly Japan and Lilly global quality network.
* Collaborate with affiliate QA to solve quality issues
* Ensure Site education and provide consultation on local regulations and corporate standards.
* Provide performance metrics, quality metrics and trend evaluations on Quality Systems, including ad-hoc, periodic review and trend evaluation of Complaints, Deviations, Change Controls, etc.
* Ensure adequate documentation control and retention in alignment with local and Lilly global requirements.
* Develop the process and ensure adequate implementation and maintenance of Management review of Quality Systems, Site Compliance Reports, gap assessment of global quality standards and local regulatory guidance documents
* Ensure adequate quality oversight is provided Material Suppliers and Service Providers.
* Develop and ensure execution and monitoring of Supplier and Service Provider quality systems, audit plan and periodic review of Supplier/Service Providers performance.
* Ensure there is an appropriate Risk Management program, risk register and QRM related elements
* Ensure there is an appropriate CAPA program

Educational…