Who You Are

At least 5 years of Quality Assurance experience in a regulated industry (pharmaceuticals, biologics, or medical devices)
Strong knowledge of GMP, GQP, and QMS regulations
Solid understanding of PMDA inspections and license inspection procedures
Demonstrated understanding of legal, regulatory, and compliance requirements
Clear grasp of the scientific background of relevant diseases and how it impacts quality processes
Excellent communication and presentation skills (verbal and written) in Japanese and English
Experience leading, mentoring, or managing team members is highly valued

What You’ll Do

Lead GQP / QMS activities as Quality Assurance Officer (Hinseki)
Manage product market release in Japan, ensuring regulatory and quality compliance
Ensure consistency between JNDA dossiers and actual operating processes
Oversee Quality and Regulatory compliance related to GMP inspections
Act as the primary QA contact for MHLW, PMDA, and Tokyo Metropolitan authorities
Introduce, implement, and maintain Quality Systems
Conduct or supervise core QA activities
Lead Corrective and Preventive Action (CAPA) processes
Perform document control and management for GQP / QMS / GDP
Plan and conduct internal audits and external supplier audits
Create and maintain Quality Agreements with Japan-based suppliers
Collaborate closely with Drug Safety / Pharmacovigilance
Communicate and negotiate with external suppliers, internal stakeholders, and Global QA
Report quality-related issues to the Marketing Supervisor General (Sokatsu)
Lead and manage the GQP team, providing guidance, coaching, and people management support