QAマネージャー/ QA Manager

A multinational life sciences company is looking for a QA Manager of DMAH/MAH. The successful candidate will oversee quality assurance activities, ensure regulatory compliance, manage GQP operations, support GMP inspections and audits, and maintain quality systems for pharmaceutical products.

Responsibilities:

• Prepare pharmaceutical documents for submission to Japanese regulatory authorities
• Manage GQP activities including review of manufacturing documents, deviations, change controls, CAPA, and batch release
• Review QA submission documents, QMS, SOPs, vendor audits, and market complaints
• Conduct GMP audits and support GMP inspections by Japanese regulatory authorities
• Provide regulatory guidance and communicate quality-related information to overseas clients
• Prepare and deliver presentations and technical documentation in English

Requirements:

• Bachelor’s degree or above in biological sciences, medicine, pharmacy, science, agriculture, or a related field
• More than 10 years of experience in Quality Assurance
• More than 3 years of experience in setting departmental goals, budget management, and training subordinates
• Scientific background with the ability to prepare pharmaceutical documents for Japanese regulatory authorities
• Strong understanding of Japanese pharmaceutical regulations, including ethical pharmaceuticals, OTC products, regenerative medical products, and Marketing Business Licences
• Experience conducting GMP audits for manufacturing sites
• Experience reviewing QA submission documents, change control assessments, batch release, QMS, SOPs, vendor audits, and market complaints
• Experience supporting GMP inspections by PMDA or other regulatory authorities
• Professional level English

Preferred requirements:

• Doctoral degree
• More than 3 years of experience as a Quality Assurance Manager or Quality Control Manager for Type I, Type II, or Regenerative Medical Product Marketing Business Licence at a pharmaceutical company or CRO
• 3-5 years of GMS experience in post-approval for medicinal products

About the Company:

A global life sciences company providing regulatory, quality, and compliance solutions to the pharmaceutical and biotechnology industries. The organisation supports clients worldwide with expertise across the product development and commercialisation lifecycle.

Keywords:

品質保証, QAマネージャー, 医薬品, 規制対応, 品質管理, ライフサイエンス, 求人, 外資系

Job Ref: 9N5Y89