【Alexion Japan】Senior Quality Auditor, Alexion Operations Audit

The Senior Quality Auditor at Alexion Rare Disease Unit (ARDU) is responsible for auditing GMP/GDP sites and suppliers to ensure compliance with regulatory and internal requirements. The role involves leading and supporting the complete audit lifecycle, conducting independent appraisals of quality and compliance systems, and providing leadership to the Audit team.

Requirements

• 12+ years’ experience in a GMP/GDP/Medical Device or related industry in a quality/compliance function
• 5+ years GMP/GDP QA experience supporting or conducting audits
• Thorough knowledge of applicable international GxP regulations and standards
• Excellent written and verbal communication skills
• Strong attention to details skills
• Strong organizational skills
• Technical writing/ reporting skills
• Ability to multi-task and prioritize work effectively
• Team-oriented approach to project management and problem resolution

Benefits

• Paid Time Off
• 401k Matching
• Retirement Plan