品質保証担当者, Consumer Health Products
Core
Lead quality assurance for commercial products across multiple regulated categories (drugs, quasi-drugs, cosmetics, medical devices) in Japan, ensuring compliance with local regulations and internal standards throughout the product lifecycle.
Role type
Senior Quality Assurance Manager (Regulatory/Compliance)
Builds
Stable quality operations and regulatory compliance for consumer health products
Domain
Consumer Health / Regulated Pharmaceuticals & Medical Devices
Required skills
Quality Assurance management, Deviation/CAPA management, Change control, Quality risk assessment, Regulatory compliance (Japan), GMP/GQP knowledge, Document review and approval, Cross-functional collaboration, Data analysis for continuous improvement
Preferred skills
Pharmacist license, Degree in Pharmacy/Chemistry or related field, Experience in regulated industries
Technologies
GMP, GQP, CAPA, Change Control Systems
Responsibilities
Maintain and operate the quality assurance system for commercial products in Japan; Lead deviations, quality investigations, CAPA, change control, and quality risk assessments across the product lifecycle; Review and approve SOPs, specifications, and quality-related documents; Manage quality control at domestic logistics centers and warehouses; Lead or coordinate investigations into non-conformities and deviations; Analyze quality data to drive continuous improvement; Collaborate with Supply Chain and Regulatory Affairs; Contribute to GMP/GQP training and awareness.
Seniority
Senior, hands-on IC with leadership responsibilities