QA Manager, External Supply Quality

• Lead quality oversight for Amgen Contract Manufacturing locations in the JAPAC region
• 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
• 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
• Perform tactical batch disposition activities in support of lot release
• Negotiate Quality Agreement terms and conditions and ensure adherence
• Perform supplier audits for key manufacturers within the JAPAC region
• Act as a key quality partner to manufacturing, supply chain, process development, and other Amgen internal functions
• Take the lead in cross-functional initiatives and continuous improvement projects
• Ensure inspection readiness for our contract manufacturing sites and internal Amgen records
• Perform person in plant responsibilities during Amgen manufacturing campaigns or to support key process steps at the contract manufacturer
• Role will require occasional travel and onsite engagement with contract manufacturing sites

• Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience in Quality and/or Manufacturing experience at small and/or large molecule drug substance or drug product manufacturing facilities
• Technical experience with synthetics/small molecules a strong plus
• Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing)
• Confident communicator who can build relationships across technical and cultural boundaries
• Track record of driving change, improving systems, and mentoring/coaching others
• Skilled in using risk based decision-making approaches
• Experience with regulatory activities and variation management

Technical experience with synthetics/small molecules a strong plus

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits