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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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

QA SR MANAGER EXTERNAL SUPPLY QUALITY (ESQ) - SUPPLIER QUALITY MANAGEMENT

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as the quality lead and subject matter expert for critical global suppliers of GMP raw materials, specifically Single Use, Resins, and Filters (SURF). You will own the end-to-end quality oversight of assigned suppliers—from onboarding through ongoing performance monitoring to disengagement—ensuring compliance, reliability, and continuous improvement. You will also act as the primary quality contact for internal stakeholders, supporting issue resolution, supplier strategy, and cross-functional initiatives. This role offers a unique chance to make a global impact while developing deep expertise in SURF materials and external quality systems.

• Act as the quality lead for supplier relationships, from onboarding through disengagement, ensuring performance through robust proactive monitoring, technical site visits, and continuous improvement.
• Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards, including but not limited to GDP, GMP, ISO, etc and Amgen’s industry leading expectations.
• Review and approve quality documentation, including Quality Agreements, deviations, supplier investigations, CAPAs, CAPA EVs, supplier change notifications and change controls, with a sharp eye for risk and compliance.
• Participate in and/or lead supplier audits and collaborate with internal and external partners to implement corrective and preventive actions.
• Prepare Amgen sites and suppliers for audits and inspections including development of inspection playbooks. Represent Amgen/ESQ during such audits and inspections - owning our quality story with confidence and clarity.
• Identify and mitigate risks at the supplier and/or escalate to management.
• Perform Person in Plant activities, as deemed appropriate.
• Drive audit commitments to completion.
• Act as a key quality partner to External Supply, Manufacturing, Supply Chain, Material Sciences, Engineering Technical Authority (ETA), Process Development and other internal functions.
• Take the lead and/or participate in cross-functional initiatives and continuous improvement projects, shaping the future of supplier quality at Amgen.
• Roles require 20% travel, both domestic and international travel.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The QA Senior Manager External Supply Quality professional we seek is a collaborative leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Quality experience OR
• Associate’s degree and 10 years of Quality experience OR
• Bachelor’s degree and 8 years of Quality experience OR
• Master’s degree and 6 years of Quality experience OR
• Doctorate degree and 2 years of Quality experience OR

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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:

• Educational background in Life Sciences
• Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
• Relevant work experience within Dru