Quality Assurance Senior Manager

• 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
• Provide quality oversight of new product introductions, tech transfers, and process qualification activities at the contract manufacturing site
• 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
• 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
• As needed, perform person in plant responsibilities during Amgen manufacturing campaigns or to support key process steps at the contract manufacturer

• Doctorate degree and 2 years of Quality and Compliance experience
• Master’s degree and 6 years of Quality and Compliance experience
• Bachelor’s degree and/or 8 years of Quality and Compliance experience
• Strong background in GMP compliance, with a focus on external manufacturing or materials management
• Significant Quality and/or Manufacturing experience at small and/or large molecule drug substance or drug product manufacturing facilities
• Proven ability to lead audits, manage complex investigations, and influence quality improvements
• Confident communicator who can build relationships across technical and cultural boundaries
• Track record of driving change, improving systems, and mentoring others within Quality
• Skilled in using risk based decision-making approaches
• Experience with regulatory activities and variation management
• Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing)

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