Quality Associate Director

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.

Quality Associate Director

What you will do

Let’s do this! Let’s change the world! In this vital role, you will serve as Amgen’s operations enterprise leader for the Supplier Quality Management (SQM) Quality Management System (QMS) processes. Reporting to the Business Performance & Quality Management System Leader, you will drive the global SQM strategy, lead digital transformation through DQMS and AI-enabled capabilities, and ensure consistent, compliant, and inspection-ready SQM execution across Amgen’s global operations and affiliate network. You will also shape and govern end-to-end SQM processes ensuring Amgen remains aligned with regulatory expectations and positioned for Quality 2032 ambitions.

As Quality Associate Director, Global Process Owner – Supplier Quality Management (SQM), you will:

• Provide enterprise leadership, governance, and decision making for the SQM QMS, including global standards, end-to-end process design, and oversight across Amgen manufacturing sites, above site organizations, global affiliates, and key external partners.

• Drive transformation of SQM capabilities by driving key decisions for Digital QMS (DQMS) initiatives, advancing digital tools, automation, AI, and analytics to enhance efficiency, maturity, and compliance.

• Lead integration of multiple SQM sub-processes including Event Notifications, Supplier Corrective Actions, and Supplier Change Notifications into one comprehensive, streamlined enterprise workflow.

• Oversee the design, implementation, and sustainment of technical releases that enable continuous evolution of the SQM digital ecosystem and support enterprise inspection readiness.

• Guide cross-functional alignment by partnering with global sites and operations above site functional areas to ensure SQM processes support business needs and regulatory expectations.

• Ensure enterprise inspection readiness for SQM by establishing robust KPIs, monitoring systems, dashboards, and governance mechanisms to predict risks, improve issue management, and support the high number global audit and inspection engagements annually.

• Lead SQM integration of new sites, programs, and acquisitions, including Rare Disease and future portfolios, ensuring seamless adoption, harmonization, and sustainable SQM capabilities.

• Develop and implement enterprise change management and communication strategies to support adoption of new technologies, standards, and processes across global functions and supplier partners for the SQM QMS and related processes.

• Represent SQM globally with regulators, partners, and industry forums to advance standard processes, benchmark performance, and ensure the QMS remains current with evolving expectations.

• Cultivate a high-performing network of SQM team members, providing guidance to senior professionals across multiple departments and sites.

• Directly manage a hard-working team of quality professionals to advance SQM aligned with Quality Strategy for 2032 ambitions.

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 a strategic, enterprise-minded Quality leader with the following qualifications.

Basic Qualifications:

• Doctorate degree and 3 years of Quality, Operations, or relevant biopharmaceutical experience OR

• Master’s degree and 7 years of Quality, Operations, or relevant biopharmaceutical experience OR

• Bachelor’s degree and 9 years of Quality, Operations, or relevant biopharmaceutical experience OR

• Associate’s degree and 12 years of Quality, Operations, or relevant biopha