Quality Assurance Senior Manager

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. This QA Sr. Manager role will be responsible for the quality oversight of primary component suppliers. This person is an integral member of the Amgen cross-functional supplier team(s) that includes, but is not limited to, business operations, process development, supply chain and combination product quality.

Key Responsibilities

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.

Negotiator and owner of quality agreements

Prepare external sites for inspections including development of inspection playbooks.

Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during notified body audits of supplier, as applicable or required

Present on topics during inspections demonstrating appropriate behaviors and knowledge of the subject areas

Review/Approve supplier investigations, events and change notifications

Quality approver of deviations, change controls, CAPA, CAPA EVs

Identify and mitigate risk at the supplier and/or escalate to management

Perform Person in Plant activities, as deemed appropriate

Drive audit commitments to completion

Lead supplier audit preparation and identify areas of focus

Continuously assess supplier status through periodic monitoring reporting

Partner with Operations site lead on issues, improvements, site performance and overall relationship management

Understand and implement GMP requirements internally and externally

The follow applies

Up to 20% of domestic and international travel required

This role may work on-site at one of the following locations: Thousand Oaks, CA, Cambridge, MA, Greenwich, RI, Tampa, FL, or Puerto Rico.

Open to remote associates in any US location

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications

Doctorate degree and 2 years of Quality experience OR

Master’s degree and 4 years of Quality experience OR

Bachelor’s degree and 6 years of Quality experience OR

Associate’s degree and 10 years of Quality experience OR

High school diploma / GED and 12 years of Quality experience