品質保証マネージャー/ QA Manager

A global pharmaceutical organisation is looking for a QA Manager. The selected candidate will lead quality assurance activities across CMOs, ensuring GMP compliance, product quality, and stable supply while working closely with internal and global stakeholders.

Responsibilities:

• Lead quality assurance activities for all manufactured and marketed products
• Ensure GMP compliance and stable supply through sound decision-making with QA leadership
• Conclude, review, and negotiate Quality Technical Agreements with domestic and overseas CMOs
• Evaluate CMO change controls in collaboration with Regulatory Affairs and SCM to protect supply continuity
• Investigate complaints and deviations, drive root cause analysis, and implement preventive actions with CMOs
• Conduct quality audits and product quality reviews to enhance GMP standards and CMO technical capabilities

Requirements:

• More than 3 years of quality assurance experience in the pharmaceutical industry

Preferred requirements:

• Experience as a quality assurance manager for prescription drugs or equivalent
• Prior experience working at a pharmaceutical manufacturing plant or at a pharmaceutical research institute

About the Company:

An international pharmaceutical organisation that provides innovative and useful healthcare products. Serving patients from more than 100 countries around the world, this company is a true industry leader.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: CZFV9O