QAマネージャー/ QA Manager

A global pharmaceutical company is looking for a Quality Assurance Manager. The selected candidate will oversee local and global QA operations, lead strategic quality projects, and ensure compliance with GxP regulations to maintain high standards of product quality and regulatory adherence.

Responsibilities:

• Lead GQP/QA operations for local and global quality management initiatives
• Oversee manufacturing sites, CMOs, and supplier quality management to ensure compliance
• Execute and manage change control, deviation/OOS management, and quality documentation
• Lead strategic quality projects and serve as QA representative in cross-functional initiatives
• Monitor quality performance indicators, risk registers, and conduct product quality reviews
• Facilitate audit readiness, regulatory inspections, and internal QA assessments
• Implement and maintain Quality Management Systems, including Veeva, TrackWise, and LMS
• Support new product introductions and technical transfers from overseas and domestic sites
• Ensure regulatory compliance with local laws, PMDA, MHLW, and corporate standards
• Collaborate with SCM, RA, CMC, and global teams to drive quality and operational excellence

Requirements:

• Experience in pharmaceutical QA operations and GxP compliance
• Proven ability to manage cross-functional teams and lead strategic projects
• Skilled in quality systems management, including Veeva, TrackWise, and LMS
• Proficient in Japanese and English

About the Company:

A global biopharmaceutical leader specialising in innovative therapies that improve patient care, offering a dynamic and supportive work environment. Known for scientific excellence and career growth opportunities, it attracts professionals seeking meaningful roles in cutting-edge healthcare and research.

Keywords:

品質保証, 製薬, 製造管理, 監査対応, 品質リスク管理, サプライヤー管理, 新製品導入, 求人, 外資系

Job Ref: AMN83W