Associate Director QA - Hinseki

• Lead quality and compliance activities for the Japan organization, ensuring alignment with global standards, GxP/GDP/PV requirements, and local regulations.
  
• Support technical transfers, validation, manufacturing oversight, and product release activities with local and global manufacturing partners.
  
• Represent Quality in CMC and commercial projects, driving inspection readiness, risk management, CAPAs, and continuous process improvement.
  
• Review and approve GMP quality documents, including investigations, change controls, validations, specifications, complaints, and batch records.
  
• Provide leadership, cross-functional collaboration, vendor management, budget oversight, and team development support.
  
  

• Ensure products are manufactured, tested, released, and distributed in compliance with SOPs, cGMP/GMP, GQP, GDP, and applicable regulatory requirements.
  
• Lead quality decision-making, including product release, rejection, recalls, returned goods disposition, and approval of saleable stock.
  
• Review and approve GMP quality documents, quality agreements, subcontracted activities, suppliers, customers, and other quality-related processes.
  
• Maintain and strengthen quality systems through training, self-inspections, record management, complaint handling, CAPAs, and continuous compliance oversight.
  
• Support implementation and ongoing maintenance of quality management systems and regulatory compliance programs.
  

Requirements

• 8+ years of Quality Assurance, Compliance, and leadership experience in the pharmaceutical or biotech industry.
  
• Strong knowledge of GxP regulations, quality systems, CMC processes, process validation, QC testing, and global regulatory requirements (e.g., FDA, EMA, PMDA).
  
• Proven ability to manage cross-functional and global matrix environments while adapting to evolving business and compliance needs.
  
• Excellent leadership, organizational, communication, and stakeholder management skills, including collaboration with external partners and laboratories.
  
• Fluent in English and Japanese.