【品質保証責任者】QA Leader & Hinseki PDx Japan
Core
Lead the Quality Assurance function in Japan to ensure compliance with GQP, GDP, and GMP regulations for medical technology products.
Role type
Senior Quality Assurance Leader (Hinseki)
Builds
Compliance with regulatory standards for medical devices and pharmaceutical products
Domain
Medical Technology / Pharmaceutical Manufacturing
Deliverable
client delivery
Required skills
Regulatory compliance (GQP/GDP/GMP), Quality Management System (QMS) oversight, CAPA management, Supplier quality audit, Risk assessment, Project management, Cross-functional leadership
Preferred skills
Pharmacist license, Hinseki/Sokatsu role experience, Sterile product QC testing, Technical transfer experience
Technologies
TrackWise, Veeva Vault, SAP, MS Teams
Responsibilities
Own QA processes including product release, complaint handling, investigations, and validation; Manage quality evaluation of warehouse operations and external labs; Engage in site inspections and prepare audit responses; Support regulatory product-specific inspections and liaise with PMDA; Lead Quality Management Reviews
Seniority
Senior, hands-on IC with management responsibilities
