Senior Quality Assurance Manager Japan

We are seeking an experienced Senior Quality Assurance Manager to lead and maintain our local Quality Management System, ensuring compliance with local regulations and global CSL Behring standards. This role is responsible for driving quality excellence across the affiliate, providing strategic quality leadership, supporting product lifecycle activities, managing supplier oversight, and partnering cross-functionally with local, regional, and global stakeholders to foster a strong quality culture and ensure the highest standards of patient safety and product quality.

Reporting to QA Head Japan

Roles & Responsibilities

• Implementation and maintenance of the Quality Management System in compliance with local regulations and CSLB standards, including but not limited to: Deviation Management o Corrective Action & Preventive Action (CAPA) Management, Product Complaints Management, Change Control Management, Documentation Management, Training Management, Recall Management, Self-Inspection Management, Quality Risk Management and recommendation for improvements to the quality system supporting CSLB business in the countries
  
• Implementation of the Quality Systems in daily operations: Quality responsibility for all CSLB products licensed, marketed, or supplied within Territory of responsibility, Compliance with local as well as international regulations (e.g. GDP) and inspection readiness, Obtain/oversee the legal documentation required license to operate in the Territory, Maintain up-to-date Quality Agreements, Develop, implement, and maintain local Quality procedural documentation (in accordance with Global policies and procedures and the local document management system, if required), Monitor performance indicators related to quality compliance, Resolve quality-related issues, Archive and maintain all quality documents in line with CSLB procedures and legal requirements

• Degree in pharmacy or life science (if required by local legislation) or equivalent experience
  
• At least 10 years of experience in the pharmaceutical industry, of which 5 years of experience in Quality Management Systems
  
• Fluent in local language and good knowledge of oral and written English
  
• Understands and has experience in pharmaceutical quality assurance systems
  
• Knowledge of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and local regulations and guidelines as applicable to the level of activities carried out at the affiliate or region
  
• Sound and balanced judgment; able to assess and handle risks; self-confident, proactive, and decisive
  
• Works and communicates effectively and collaboratively across affiliate functions and other global CSL functions and external partners or third parties