R&D Supplier Quality Manager

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity‑related conditions, rare diseases, inflammatory conditions and cancer.

As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team.

Join us and transform the lives of patients while transforming your career.

What you will do Let’s do this. Let’s change the world. Amgen is seeking a highly motivated R&D Supplier Quality Manager to support the qualifications, oversight, and continuous improvement of suppliers that contribute to Amgen’s R&D pipeline and our mission to serve patients. In this role you will support the operational execution of supplier quality management processes for R&D suppliers under GCP, GLP, and GPvP regulations, including suppliers that provide, host, develop, validate, maintain, or support GxP computerized systems used to support regulated preclinical and clinical activities.

Working cross-functionally with stakeholders across Quality, Procurement, R&D, Information Systems, Cybersecurity, Privacy, and business process owners, you will provide hands‑on oversight of third‑party suppliers to ensure compliance, data integrity, patient safety, risk mitigation, and continuous improvement across the supplier lifecycle.

• Conduct risk-based supplier assessments, qualification, audit and lifecycle management, including quality agreements across various R&D service categories.
• Lead or support risk-based qualification and ongoing oversight of suppliers that utilize and/or provide GxP computerized systems, interfaces and devices to support clinical and preclinical activities.
• Assessment and oversight of supplier AI-Enabled GXP computerized systems used to support clinical and preclinical activities ensuring compliance to defined procedural controls, policies and standards.
• Plan, lead, and document risk-based audits of supplier GxP computerized systems and associated quality processes to assess regulatory compliance, validation and lifecycle controls, data integrity, security, and the effectiveness of corrective and preventive actions.
• Assess supplier quality systems and controls for computerized system lifecycle management, including validation, data integrity, security, access management, change and configuration management, incident and problem management, backup, recovery, business continuity, and decommissioning.
• Review risk-appropriate quality and technical requirements in supplier contracts and quality agreements, including validation documentation, audit trails, electronic records and signatures, subcontractor controls, regulatory inspection support, data ownership, data retention, and notification of significant changes or incidents.
• Participate in supplier governance and periodic reviews; evaluate service performance, validation status, changes, deviations, incidents, audit outcomes, emerging risks, and CAPA effectiveness, and elevate material GxP or data integrity concerns.
• Support inspection readiness and regulatory responses…