Senior Manager, External Supply Quality - Remote

Overview

Join Amgen as a Senior Manager in External Supply Quality, where you will lead quality oversight for contract manufacturing locations in Japan and ensure compliance with global GMP standards.

In Short

• Lead quality oversight for contract manufacturing sites.
• Ensure compliance with global GMP standards.
• Drive proactive quality management of suppliers.
• Provide quality oversight for new product introductions.
• Review and approve quality documentation.
• Negotiate Quality Agreement terms.
• Manage audit and inspection commitments.
• Lead a team of quality professionals.
• Support continuous improvement projects.
• Occasional travel may be required.

Requirements

• Bachelor or Master’s degree in a relevant field.
• At least 6 years of Quality and Compliance experience.
• Strong background in GMP compliance.
• Excellent communication skills in English and Japanese.
• Experience in quality and manufacturing at drug substance and product facilities.
• Proven ability to lead audits and manage investigations.
• Skilled in risk-based decision making.
• Experience with regulatory activities in Japan.
• Knowledge of analytical testing methods.
• Ability to build relationships across cultural boundaries.

Benefits

• Continuous learning and career support.
• Comprehensive Total Rewards package.
• Opportunities for international collaboration.
• Supportive and inclusive culture.
• Valued expertise and voice.