QA Manager (MAH)

• Accurate and in-depth understanding of regulations governing the application, approval, and maintenance of ethical pharmaceuticals, OTC products, and regenerative medical products in Japan.
  
• Practical experience reviewing QA-related submission documents, evaluating change controls, managing batch release of commercial products, overseeing QMS and SOPs, conducting vendor audits, and handling market complaints.
  
• Working knowledge of regulatory requirements for maintaining Type I, Type II, or regenerative medical product Marketing Business Licenses.
  
• Demonstrated responsibility for GQP (Good Quality Practice) activities, including review of manufacturing documentation, deviation management, change control, and CAPA, in compliance with Japanese regulations.
  

Requirements

• Strong scientific background with the ability to prepare pharmaceutical documentation for submission to Japanese regulatory authorities (PMDA and MHLW).
  
• Proficiency in reviewing English-language documents and correspondence from global clients and providing timely, accurate written responses in English.
  
• Ability to clearly communicate and explain Japanese regulatory requirements to overseas clients and stakeholders.
  
• Experience preparing meeting materials using presentation tools (e.g., PowerPoint) and delivering presentations in English.
  
• Hands-on experience conducting GMP audits of manufacturing sites.
  
• Experience supporting GMP inspections conducted by PMDA or other regulatory authorities in Japan; prior experience with PMDA-led inspections is preferred.
  
• Minimum of three years’ experience as a Quality Assurance Manager or Quality Control Manager supporting Type I, Type II, or regenerative medical products under a Marketing Business License; experience in a pharmaceutical company or CRO is preferred.