QAマネージャー/ QA Manager

A global regulatory solutions company is seeking a QA Manager of DMAH/MAH. The selected candidate will oversee GQP activities and ensure full compliance with Japan’s regulatory requirements.

Responsibilities:

• Manage GQP tasks including manufacturing record review and deviation management
• Oversee change controls, CAPA, and quality-related documentation
• Review QA submission documents and assess change control impact
• Lead commercial batch release processes and ensure QMS compliance
• Maintain and update SOPs, conduct vendor audits, and handle market complaints
• Ensure adherence to Japanese pharmaceutical regulations and quality practices
• Serve as a QA Manager, collaborating closely with the RA and CMC teams to provide end-to-end client support up to the delivery of regenerative medicines

Requirements:

• Bachelor’s degree or above in biological sciences (medicine, pharmacy, science, agriculture, etc.)
• 2-3 years of experience in QA
• Experience in conducting the GMP audit for manufacturing site
• Prior experience in reviewing all QA submission documents, change control assessment, batch release of commercial products, QMS, SOPs, vendor audit market complaints, etc.
• Proven experience in supporting GMP inspections by PMDA or authority in Japan (other countries are ideal)
• Background in preparing pharmaceutical documents to be submitted to Japanese regulatory authorities (PMDA and MHLW)
• Prior background in GMP audit by PMDA is a plus
• Knowledge of the regulations related to the application and approval of ethical pharmaceuticals, OTC, or regenerative medical products
• Native level Japanese; proficient in English

About the Company:

A leading global provider of regulatory solutions and services, specialising in compliance, labeling, and regulatory affairs support. Offers end-to-end expertise across pharmaceuticals, medical devices, cosmetics, and food supplements industries.

Keywords:

医薬品品質保証, 規制対応, 医療機器, 品質管理, 求人, 外資系

Job Ref: S8E2G8