Senior Specialist, Quality Risk & Governance

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. 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.

Senior Specialist, Quality Risk & Governance

What you will do

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

At Amgen, quality is more than compliance — it is a strategic capability that enables innovation, operational resilience, and trust across the product lifecycle. We are seeking a Senior Specialist, Quality Risk & Governance to help strengthen and evolve our enterprise GxP Quality Management System through proactive risk management and effective governance practices.

This role combines a strong emphasis on Quality Risk Management (60%) with strategic and operational support for GxP Governance (40%), helping ensure enterprise-wide visibility, escalation, decision-making, and continuous improvement across GxP domains.

The successful candidate will partner cross-functionally with Quality, Manufacturing, Supply Chain, Regulatory, Clinical, Pharmacovigilance, and Digital organizations to drive a modern, data-driven approach to quality oversight and governance. This position is ideal for a professional who thrives in matrixed environments, enjoys solving complex organizational challenges, and is passionate about advancing proactive quality cultures. This role is preferred to be hybrid, within close proximity to one of our Amgen locations. Remote will be considered if applicable.

Quality Risk Management (60%)

In this role, you will support the development, execution, and continuous improvement of enterprise GxP Quality Risk Management programs and processes across multiple GxP domains (GMP, GCP, GLP, GVP, GDP, etc.).

Key Responsibilities

• Support implementation and continuous improvement of enterprise Quality Risk Management (QRM) frameworks aligned with global regulatory expectations.

• Facilitate risk identification, assessment, mitigation, escalation, and monitoring activities across GxP functions and sites.

• Partner with cross-functional stakeholders to identify emerging compliance and operational risks across the product lifecycle.

• Support development and monitoring of Key Risk Indicators (KRIs), quality metrics, and risk dashboards to enable proactive decision-making.

• Conduct risk trending, signal analysis, and data evaluation to identify systemic issues and opportunities for mitigation.

• Assist with governance and oversight of enterprise risk registers, risk review forums, and escalation pathways.

• Collaborate with Digital and Quality Systems teams to support risk management process integration within Veeva or other quality technology platforms.

• Support inspection readiness activities and provide SME support during internal audits and regulatory inspections related to risk management processes.

• Contribute to development of training materials and risk management capability-building initiatives across the organization.

• Monitor industry trends, regulatory updates, and emerging technologies related to Quality Risk Management and digital quality transformation.

Governance & Management Review (40%)

You will also support enterprise GxP Governance activities designed to strengthen management oversight, process health, accountability, and cross-functional alignment.

Key Responsibilities

• Support execution and continuous improvement of enterprise GxP Governance and Management Review processes.

• Coordinate governance meetings, governance committee materials, metrics reporting, and follow-up actions.

• Assist in maintaining governance frameworks, charters, roles/responsibilitie