Executive Director, GxP Quality Systems Platform

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-related conditions. As a member of the Amgen team, you will 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.

Executive Director, GxP Quality Execution Platforms

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the strategy, operating model, and lifecycle ownership for enterprise GxP Quality Execution Platforms. This role converts core quality processes from manual, process-centric execution into scalable, workflow-, rule-, and data-driven digital platforms that are inspection-ready, adoption-led, and aligned with the GxP Quality Operating Model.

Responsibilities:

• Operationalize the GxP Quality Operating Model vision and strategy evolving from digitized Quality Management System through AI-enabled to advanced AI-orchestrated with full autonomy across foundational quality processes. Relevant to that, own business strategy includes driving development and endorsement of business case needs for funding, roadmap, and lifecycle governance for enterprise GxP quality execution platforms, including event and issue management, audit/inspection mgmt., document and knowledge, change control, supplier management, and other priority execution workflows.

• Partnering across sites and functions, process, and technology requirements inclusive of control requirements, workflow and business-rule requirements, escalation requirements, user needs, and business acceptance criteria that translate into measurable business outcomes.

• Drive the evolution from process-centric Quality Management System (QMS) operations toward platform-enabled quality execution consistent with the future-state Quality Operating Model supporting the GxP continuum. This is inclusive of developing the organizational construct required to sustain this digital QMS evolution. Directionally role will oversee a group of 10 to 15 professional staff from Sr. Director to Specialist level as appropriate based on design of organization.

• Establish platform operating disciplines for intake, prioritization, release governance, defect management, service health, and value realization.

• Partner with R&D, Operations, Quality, Regulatory, Enterprise Technology & Data Governance (ETDG), and external partners to ensure platform solutions meet business, compliance, and inspection-readiness expectations.

• Lead adoption, process harmonization, and business readiness for deployed platforms, including role-based enablement and performance support.

• Define platform health metrics, operational KPIs, and value measures tied to quality, compliance, speed, user experience, and ROI.

• Ensure platforms are designed and operated in a manner that supports auditability, contemporaneous evidence, data integrity, and sustainable lifecycle management.

• Serve as the senior quality business owner for platform priorities and represent the platform portfolio in executive governance and health authority discussions, as needed.

What this role owns:

• Business ownership of GxP Quality Execution Platforms. This role may have operational execution of one or more of these workflows as well as the overall capabilities of QOSS evolves.

• Digital Platform roadmaps and investment priorities for each workflow and business-rule implementation in the platforms

• Platform operations, release governance, and service performance translated into significant Return on Investment and business outcomes

• User adoption, process harmonization, and business readiness

• Translation of governance and control requirements into platform design

Critical role inte