- ・Responsible for quality oversight and regulatory compliance of products marketed in the country, including product release and Quality aspects of the product life cycle management.
・Responsible for quality approval and management of local 3rd party service providers/suppliers/manufacturers/distributers.
・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
・To establish and maintain Quality procedures, in accordance with Mylan’s Quality Policies and SOPs, as well as with Local Requirements, to ensure the Quality, Safety and Compliance of Mylan’s products and services.
・To analyze and provide disposition on Quality processes (not limited to): Changes impacting GxPs, Quality Deviations, Quality parts of Regulatory submissions, Customer Complaints, Quality Technical Agreements, Field Actions, Supplier Qualification and Approval
・To provide support and/or be part of Mylan’s “Sanyaku”.
・To represent Quality Division in internal/external meetings and committees, including Quality related projects and associations.
・To appropriately perform talent management in order to hire manage and retain talents within the department.
- 経験・スキル 必須要件
・10 years’comprehensive Quality experience with pharmaceutical companies
・Deep knowledge of ICH, GQP/GMP regulations
・Experience as Sokatsu and/or Hinseki
・R&D experiences in CM&C area.
・Working experiences in manufacturing or laboratory
・Managerial experience including team-building and human resources development
・Strong leadership, communication, creative and analytical skills
・Mentor and coach team members as the team leader, reviewing their progress and field reports
・Strong communication and presentation skills; able to interface at all stakeholder levels
・Negotiation skill with business related authorities, business partner and supplier.
・英語力 Business Level (TOEIC800)