QAマネージャー/ QA Manager

An international pharmaceutical company is looking for a Quality Assurance Manager. The selected candidate will lead quality oversight of external manufacturing partners, ensure GxP compliance, and drive continuous improvement across manufacturing and supply operations.

Responsibilities:

• Lead quality oversight for Contract Manufacturing Organisations and act as the primary QA contact
• Review and approve cGMP documents, including Organisations ' batch records, validations, deviations, CAPA, and quality agreements
• Manage product release in accordance with approved specifications and procedures
• Monitor contractor performance using KPIs and escalate adverse quality trends
• Support CMO operational management and pharmaceutical project activities
• Maintain and improve internal quality systems, including site quality reviews and self-inspections
• Ensure compliance with GxP, marketing authorisation requirements, and internal procedures

Requirements:

• Bachelor’s degree or above in Pharmacy or Chemistry
• More than 5 years of experience in biopharmaceutical manufacturing or QA/QC
• Experience in GMP, GQP, GDP, validation, batch record review, and product release
• Proficient in biological manufacturing, sterile products, and Japanese dossier review
• Experience communicating with Japanese health authorities
• Native level Japanese; business level English

Preferred requirements:

• Experience in CMC Regulatory and sterile manufacturing

About the Company:

A global healthcare leader with deep expertise in pharmaceuticals and life sciences, this organisation is dedicated to discovering and delivering innovative medicines and vaccines that improve patient outcomes worldwide. With a strong focus on research, advanced technology, and collaborative innovation, it offers dynamic career opportunities for professionals seeking growth in a mission-driven, international environment.

Keywords:

品質保証, 製造委託管理, 医薬品品質, バリデーション, 製品出荷判定, 薬事対応, 生物製剤, 滅菌製品, 求人, 外資系

Job Ref: HHIVH8