R&D Supplier Quality Manager

Amgen

Remote, USA

Pay: $104,287-$141,095/yr

United States - Remote

JOB ID:

R-257817 LOCATION

United States - Remote

WORK LOCATION TYPE

Remote

DATE POSTED

Oct. 13, 2026

CATEGORY

Quality

SALARY RANGE

104,287.35USD -141,094.65 USD

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.

**R&D Supplier Quality Manager**

**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.

**Key Responsibilities**

• 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 escalate material GxP or data integrity concerns.
• Support inspection readiness and regulatory responses related to supplier’s computerized systems; partner with system owners and subject-matter experts on supplier risk acceptance, remediation, continuity, transition, and exit decisions.
• Monitor supplier performance, track KPIs, and escalate quality issues when appropriate.
• Coordinate and/or execute supplier audits, manage findings, initiate quality records, and ensure timely CAPA closure.
• Maintain supplier data in quality systems (e.g., Veeva, TrackWise) to ensure accuracy and inspection readiness.
• Engage with suppliers to align requirements, governance and process improvement initiatives.
• Ensure compliance with procedures, perform quality checks, and contribute to continuous improvement.
• Collaborate with internal teams (R&D, Supply Chain, Sourcing, QA) to assist in the development and execution of supplier quality strategies.

**Travel**

• Up to 10% domestic and international travel may be required for supplier engagements and audits.

**What we expect of you**

We are all different, yet we all use our unique contributions t