QAマネージャー/ QA Manager

A global clinical diagnostics company is looking for a QA Manager. The selected candidate will lead cross-organisational quality assurance initiatives, drive collaboration across multiple diagnostics operating companies, support quality management systems, and lead quality improvement projects.

Responsibilities:

• Build and develop new quality assurance teams during organisational transformation
• Lead cross-operating company quality assurance collaboration and initiatives
• Promote effective collaboration across multiple diagnostics organisations
• Develop relationships with stakeholders across organisations and cultures
• Drive operational improvements through quality and business system initiatives
• Lead projects using continuous improvement methodologies
• Support the development of a local cross-entity Centre of Excellence

Requirements:

• More than 5 years of experience in Quality Assurance within the pharmaceutical, medical device, and/or IVD industries
• Experience as a Domestic Quality Assurance Manager and/or So-Kats role in MAH
• Experience leading teams
• Advanced knowledge of QMS based on ISO13485
• Ability and willingness to travel
• Native level Japanese; business level English

Preferred requirements:

• Experience as a project lead
• Possess a valid Pharmacist licence

About the Company:

The company operates in the life sciences, diagnostics, and biotechnology industry. It is a global leader in clinical diagnostics, providing innovative testing solutions used by hospitals, laboratories, and healthcare professionals worldwide.

Keywords:

品質保証, QAマネージャー, 医療機器, 体外診断用医薬品, 品質マネジメントシステム, プロジェクト管理, 継続的改善, ライフサイエンス, 求人, 外資系

Job Ref: OXZG00