Senior Quality Assurance Manager Japan
Core
Lead and maintain the local Quality Management System for CSL Behring Japan, ensuring compliance with local regulations and global standards while driving quality excellence across the affiliate.
Role type
Senior Quality Assurance Manager (Pharmaceuticals)
Builds
Quality systems, regulatory compliance, and patient safety protocols for CSL Behring products in Japan.
Domain
Pharmaceuticals / Life Sciences / Quality Management
Deliverable
client delivery
Required skills
Quality Management Systems (QMS), Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), regulatory compliance, risk assessment, supplier qualification, recall management, audit management, batch release, CAPA management.
Preferred skills
Strategic quality leadership, cross-functional partnership, health authority inspection coordination.
Technologies
SAP
Responsibilities
Implement and maintain the Quality Management System; manage deviations, CAPA, complaints, change control, and recalls; oversee supplier and customer qualification; host health authority inspections; manage product returns and batch release; serve as primary contact for local regulatory agencies.
Seniority
Senior, hands-on IC with strategic leadership
