17208 Senior QA Manager
・Manage and supervise all quality operations and assurance activities at the office to ensure and improve product quality and safety
・Responsible for the Commercial Operations Quality (both domestic manufactured and imported products).
・Labor management and human resource development in the Japan Quality Assurance function.
・Safety control, document control, and expense control related to activities by the Quality Assurance function.
・Management and supervision of the Quality Management System (QMS) Group, Manufacturing Quality Group and Post Market Vigilance Group (3 teams)
・Cooperation with RA and all other cross-functional team within the company
・Lead and support business initiative as required by the business.
・Bachelor’s degree or higher, ideally in a science or technical discipline or equivalent combination of education and experience.
・Knowledge in production and use of products
・Communication skills required in collaboration with relevant sections and an ability to write logically
・Must be fluent in Japanese (speaking, reading and writing), business- business to advanced level English
・Fully understand Japan’s standards and regulations in QRA field
・Ability to prioritize and take actions systematically while making timely decisions
・Ability to write explanations and justification that are supported with data in a clear and convincing manner, Review various types of documentation for regulatory acceptability
・Patience, tenacity, and creativity in problem solving