品質保証マネージャー/ QA Manager

A multinational pharmaceutical company is hiring a QA Manager. The selected candidate will ensure quality oversight and compliance across CMO vaccine operations and internal quality systems.

Responsibilities:

• Oversee CMO vaccine operations as the primary Quality site contact
• Review and approve cGMP documents, batch records, validations, and release documentation
• Manage product release in alignment with specifications and procedures
• Monitor contractor performance against KPIs and escalate adverse trends
• Support QA activities related to CMO operations and project initiatives
• Contribute to internal QA systems including documentation, audits, and quality reviews

Requirements:

• Bachelor’s degree or above in pharmacy or chemistry
• More than 5 years of experience in biopharmaceutical manufacturing or QC/QA
• Experience in CMC Regulatory is a plus
• Prior experience in vaccine is a preferred
• Proven experience in QA
• Background in validation (process, analytical, shipping), batch record review, product release
• Prior background in reviewing Japanese dossier
• Proven background in communicating with Japanese health authority
• Knowledge of GMP/GQP/GDP
• Understanding of biological manufacturing (cell culture, sterile)
• Native level Japanese; business level English

About the Company:

A multinational pharmaceutical firm that delivers treatment options that could save lives, the company aims to increase access to medical treatment for global patients.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: VVLU0C