Head of QA

Lead quality assurance activities to ensure compliance with Japanese GQP regulations and global quality standards within a pharmaceutical environment. Responsible for overseeing quality systems, monitoring quality metrics, driving continuous improvement initiatives, and supporting organizational quality objectives.

Key responsibilities include acting as the designated quality assurance manager under GQP requirements, collaborating with internal and external manufacturing and supplier partners in both Japanese and English, maintaining alignment with global quality policies and standards, and leading the development and performance of the QA team.

Requirements

Ideal Background & Experience

• Advanced degree in a scientific discipline preferred
  


• Experience in QA/QC roles under GMP/GQP environments
  


• Business-level English and Japanese communication skills
  


• Strong knowledge of GMP/GQP regulations and global regulatory compliance requirements
  


• Experience with deviation/OOS investigations, quality agreements, supplier or CMO management, and risk management processes
  


• Ability to develop and implement quality policies and procedures
  


• Strong interpersonal, communication, presentation, and stakeholder management skills
  


• Comfortable managing multiple priorities in a cross-functional and multicultural environment
  


• Experience in sterile pharmaceutical or biologics manufacturing is an advantage
  


• Quality auditor certification is a plus
  

Benefits