Manager QA

Career Category

Operations

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. 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.

Manager QA

What you will do

Let’s do this! Let’s change the world!

In this vital role, you will lead Quality Assurance teams responsible for Incoming Quality, Raw Material and Product Disposition, and Quality oversight of Warehouse operations. The team supports the inspection, sampling, and testing of incoming raw materials and components; makes disposition decisions for raw materials and product; and provides Quality oversight of ARI warehouse operations, including floor support, receiving, sampling, dock operations, and shipping.

These responsibilities are closely connected: incoming material controls and warehouse practices support timely, compliant disposition and ultimately help ensure patients receive quality products. You will work broadly across the site and with network partners, including the global disposition network, to resolve issues and influence process improvements.

You will hire, develop, and lead Quality professionals, establish clear priorities, and foster a positive learning environment focused on quality, accountability, and continuous improvement.

Responsibilities include the following:

• Lead and empower teams responsible for Incoming Quality, Raw Material and Product Disposition, and warehouse Quality oversight.
• Oversee incoming material inspection, sampling, testing , documentation review, disposition and related Quality activities.
• Ensure raw material and product disposition decisions are timely, well documented, risk based, and consistent with approved procedures.
• Monitor key metrics across Incoming Quality and disposition to assess process health, identify trends, and lead improvement actions.
• Provide Quality oversight of warehouse operations, including receiving, material status control, storage, handling, dock activities, and shipping.
• Oversee the Raw Material Reject Cage and ensure rejected materials are appropriately controlled and managed.
• Provide Quality guidance for deviations and change controls, including assessment of potential impact to product quality, compliance, and supply.
• Lead resolution of impactful events using risk-based judgment, balanced thinking, and cross-functional collaboration.
• Review and approve cGMP processes, procedures, documents, and records, including nonconformances, deviations, CAPAs, change controls, validations, and raw material and drug substance documentation.
• Ensure changes that could affect product quality or compliance are assessed and managed in accordance with applicable procedures.
• Develop team capability through hiring, onboarding, training, coaching, and performance management.
• Communicate team goals, priorities, and performance expectations; coordinate actions to improve team and overall QA performance.
• Develop or contribute to procedures, standards, and operating practices that support consistent and compliant execution.
• Facilitate continuous improvement at the site and network levels across Incoming Quality, disposition, and warehouse quality processes.
• Represent QA on site, project, and network teams, including the global disposition network, and contribute to process direction and improvement.
• Partner with Supply Chain, Manufacturing, Quality Control, warehouse teams, and other stakeholders to resolve issues, establish direction, and support compliant and timely operations.
• Support audits and inspections related to the team’s areas of responsibility.
• Escalate quality, compliance, supply, and safety risks to senior management.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated 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 or and 5 years of Quality experience OR
• Master’s degree and 3 years of Quality experience OR
• Doctorate degree

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