R&D Supplier Quality Manager

Career Category

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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. R&D Quality is developing a Supplier Quality Oversight capability with the primary objective of delivering a robust, risk-based supplier quality program capable of identifying key leading indicators which will predict and prevent critical quality issues.

This role as R&D Supplier Quality Manager will report to the Director or Sr. Manager, R&D Supplier Quality Management in Precision Medicine, Diagnostics and Supplier Quality (PMDSQ) and will be responsible for the operational execution of supplier quality management processes for R&D suppliers operating under GCP, GLP, and GPvP regulatory frameworks. This tactical role will focus on hands-on quality oversight of third-party suppliers to ensure compliance, mitigate risks, and promote continuous improvement across the supplier lifecycle—from onboarding to issue management and offboarding.

This position plays a critical role in implementing the R&D Supplier Quality Management program, ensuring alignment with Amgen’s internal quality standards, procedures, and regulatory obligations. The ideal candidate is diligent, action-driven, and adept at performing cross-functional quality processes in a matrixed global environment.

Key Areas of Responsibility:

• Complete supplier qualification and oversight activities by conducting risk-based assessments, supporting the development, review, and lifecycle management of supplier quality agreements, and ensuring compliance with GCP, GLP, and GPvP regulations.

• Monitor and report R&D Supplier Quality performance metrics by tracking KPIs, identifying quality trends to ensure timely and appropriate escalation

• Lead supplier audit coordination by organizing supplier audits, capturing findings, initiating quality records, and tracking timely closure of CAPAs.

• Manage and maintain supplier quality data in electronic quality systems (e.g., Veeva, TrackWise), ensuring data accuracy, traceability, and audit/inspection readiness.

• Foster collaborative partnerships and manage supplier relationships by working with R&D, Supply Chain, Procurement, and Quality Assurance to align on supplier onboarding and operational requirements; engaging with external suppliers and contract organizations under mentorship; and supporting governance and cross-functional initiatives led by senior staff.

• Drive compliance to procedures and documentation standards by following SOPs, performing peer quality checks, and supporting continuous improvement initiatives.

• Willing and able to travel up to 15%

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek has technological literacy and leadership skills and has these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 3 years of relevant experience OR

• Bachelor’s degree and 5 years of relevant experience OR

• Associate’s degree and 10 years of relevant experience OR

• High school diploma / GED and 12 years of relevant experience

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Experience within the pharmaceutical/biotech or medical device industry working in quality management systems role or other relevant experience in a clinical research e