About this role
About the Role
Role focused on quality oversight for Internal Amgen Quality Records and external Amgen Contract Manufacturing locations in Japan. You will have regional responsibilities across manufacturing sites and operate at the intersection of quality, innovation, and global collaboration to ensure a reliable and quality supply of Amgen products. This role is JAPAC-based with strong technical communication skills in both Japanese and English.
What You'll Do
- Review and approve quality documentation, including master batch records, deviations, CAPAs, product complaints, and change controls, with a sharp eye for risk and compliance.
- Perform tactical batch disposition activities in support of lot release.
- Negotiate Quality Agreement terms and conditions and ensure adherence.
- Act as a key quality partner to manufacturing, supply chain, process development, and other Amgen internal functions and build meaningful and trusting team relationships.
- Take the lead in cross-functional initiatives and continuous improvement projects to improve regional operations and daily tasks.
- Ensure inspection readiness for our contract manufacturing sites and internal Amgen records. Support management of audit/inspection commitments to completion. Represent Amgen at product-specific regulatory inspections of the contract manufacturing site.
- Lead supplier audits on behalf of Amgen for suppliers located in the JAPAC region.
- As needed, perform person in plant responsibilities during Amgen manufacturing campaigns or to support key process steps at the contract manufacturer.
- Provide quality oversight of new product introductions, tech transfers, and process qualification activities at the contract manufacturing site.
- Drive proactive quality management of suppliers, ensuring compliance with global GMP standards and Amgen’s high expectations.
- Role may require occasional travel and onsite engagement with contract manufacturing sites.
What We're Looking For
- A quality professional who thrives in a dynamic, matrixed environment and is passionate about driving performance and fostering collaboration.