Who You Are
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At least 5 years of Quality Assurance experience in a regulated industry (pharmaceuticals, biologics, or medical devices)
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Strong knowledge of GMP, GQP, and QMS regulations
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Solid understanding of PMDA inspections and license inspection procedures
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Demonstrated understanding of legal, regulatory, and compliance requirements
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Clear grasp of the scientific background of relevant diseases and how it impacts quality processes
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Excellent communication and presentation skills (verbal and written) in Japanese and English
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Experience leading, mentoring, or managing team members is highly valued
What You’ll Do
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Lead GQP / QMS activities as Quality Assurance Officer (Hinseki)
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Manage product market release in Japan, ensuring regulatory and quality compliance
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Ensure consistency between JNDA dossiers and actual operating processes
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Oversee Quality and Regulatory compliance related to GMP inspections
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Act as the primary QA contact for MHLW, PMDA, and Tokyo Metropolitan authorities
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Introduce, implement, and maintain Quality Systems
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Conduct or supervise core QA activities
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Lead Corrective and Preventive Action (CAPA) processes
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Perform document control and management for GQP / QMS / GDP
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Plan and conduct internal audits and external supplier audits
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Create and maintain Quality Agreements with Japan-based suppliers
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Collaborate closely with Drug Safety / Pharmacovigilance
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Communicate and negotiate with external suppliers, internal stakeholders, and Global QA
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Report quality-related issues to the Marketing Supervisor General (Sokatsu)
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Lead and manage the GQP team, providing guidance, coaching, and people management support