【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, managing systems, rules, and processes for product quality and regulatory adherence.
Role type
Senior Quality Assurance Leader (Hinseki)
Builds
Quality Management Systems, compliance frameworks, and regulatory strategies for medical technology products
Domain
Pharmaceutical/Healthcare Manufacturing and Regulatory Compliance
Required skills
Regulatory compliance (GQP/GDP/GMP), Quality Management Systems (QMS), CAPA management, Audit preparation and execution, Risk assessment, Cross-functional leadership, Project management, Root cause analysis, Strategic planning
Preferred skills
Pharmacist license, Hinseki/Sokatsu experience, MNC pharmaceutical background, CA/PA systems 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, CAPA, validation, and change control; Lead Quality Management Reviews; Manage quality evaluation of warehouses and manufacturing sites; Engage in regulatory inspections and audits; Support global supplier quality audits; Liaise with regulators (PMDA, Tokyo Metropolitan Office Health Authority)
Seniority
Senior, hands-on IC with management responsibilities
