About the role
AI summarisedQA Manager, External Supply Quality role at Amgen in Singapore Manufacturing - Tuas.
BiotechOnsiteQuality
Key Responsibilities
- In this position, you’ll lead quality oversight for Amgen Contract Manufacturing locations in the JAPAC region.
- You will have regional responsibilities across manufacturing sites and operate at the intersection of quality, innovation, and global collaboration to ensure reliable and quality supply of our products.
- This role will be located in Singapore and will require occasional travel to contract manufacturing locations located in China, Japan, Singapore, and India.
- Candidates located in other JAPAC regions may be considered based on
Requirements
- In this influential role, you will: Drive proactive quality management of suppliers, ensuring compliance with global GMP standards and Amgen’s high expectations.
- Act as the quality lead for supplier relationships, ensuring performance through robust monitoring, technical site visits, and continuous improvement.
- Review and approve quality documentation, including master batch records, deviations, CAPAs, product complaints, and change controls, with a sharp eye for risk and compliance.
- Provide quality oversight and approval steps for new product introductions, tech transfers, analytical and method qualifications and validations, and process qualification activities at the contract manufacturing site.