【Alexion Japan】 Associate Director, Japan Country Quality

The Associate Director, Japan Country Quality is responsible for ensuring compliance with Alexion's global quality and compliance systems and regulations. The role requires leadership and resource management to ensure the roll out and on-going compliance to global quality and compliance systems, and associated procedures and standards to the JP organization.

Requirements

• 8+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/biotech industry.
• Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
• Thorough knowledge of CMC science such as the process validation, QC testing and so on
• Good knowledge of government regulations and guidelines (local, EMA, FDA, PMDA) pertaining to GXP and Pharmacovigilance required
• Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.

Benefits

• Equal Employment Opportunity and Affirmative Action employer
• Commitment to fostering a culture of belonging where every single person can belong because of their uniqueness