Job Title: QA Manager
Location: Nishishinbashi, Tokyo
Overview
Seeking a QA Manager to oversee GVP operations and post-market surveillance activities, ensuring compliance with Japanese regulations and alignment with global standards. This role will act as Safety Controller (Anseki) and provide expertise in regulatory and quality processes.
Key Responsibilities
Develop and maintain GVP processes that meet local regulatory requirements and international standards.
Serve as Safety Controller (Anseki) and lead GVP operations.
Act as subject matter expert for post-market surveillance in Japan.
Collaborate with management to implement and embed process improvements.
Build strong relationships with local leadership to identify efficiency and innovation opportunities.
Introduce new processes or tools to enhance operational performance.
Support Quality Management System (QMS) activities when required.
Qualifications
Experience in post-market surveillance, GVP, or regulatory/quality functions in the medical device or pharmaceutical sector.
Strong knowledge of Japanese GVP requirements and related regulations.
Demonstrated ability to lead cross-functional projects and influence diverse stakeholders.
Excellent communication, problem-solving, and organizational skills.
Japanese and English language skills preferred.