Manager, Japan Country Quality

Responsibilities

• Manage the GQP QA group in Japan in accordance with Global Alexion policies and SOPs
• Ensure compliance with GQP and GMDP standards through QMS management and APJ procedure development
• Oversee post-marketing product quality management systems and manufacturing site certification
• Support the Quality Assurance Manager and General Manager in maintaining marketing authorization holder systems
• Lead various project meetings, including QA weekly/monthly meetings and QMS change/deviation meetings
• Collaborate cross-functionally with Safety, Supply Chain, Medical, Regulatory, CMC, and Commercial teams
• Coordinate with regulatory authorities and co-promotion partners to ensure quality compliance

Requirements

• Bachelor's degree in a relevant scientific or technical field
• 5+ years of experience in the pharmaceutical or biotechnology industry
• Technical experience in CMC and QA/QC (manufacturing or analytical)
• Strong knowledge of JPAL, GQP, and GMP requirements
• Expertise in Quality Management Systems (QMS)
• Proven project management, problem-solving, and leadership skills
• Excellent communication, negotiation, and facilitation abilities

About the Company

Alexion is a leading biopharmaceutical company dedicated to developing life-changing therapies for people with rare diseases. As part of AstraZeneca, we foster a culture of belonging and innovation to deliver transformative medicines to patients worldwide.