Executive Director, Quality Systems GxP Platform Lead

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. We are seeking an experienced leader to fill the role of Executive Director, GxP Quality Execution Platforms. In this vital role, you will lead the strategy, operating model, and lifecycle ownership for enterprise GxP Quality Execution Platforms, converting core quality processes from manual, process-centric execution into scalable, workflow-, rule-, and data-driven digital platforms.

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.
• Own business strategy, including driving development and endorsement of business case needs for funding, roadmap, and lifecycle governance for enterprise GxP quality execution platforms.
• Partner across sites and functions to define process, technology, and control requirements for platform solutions.
• Drive the evolution from process-centric Quality Management System (QMS) operations toward platform-enabled quality execution consistent with the future-state Quality Operating Model.
• Establish platform operating disciplines for intake, prioritization, release governance, defect management, service health, and value realization.
• 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.

Qualifications

• Doctorate degree & 6 years of Quality, Operations, Product Development, Digital or related functions experience with demonstrated expertise in Digital Quality inclusive of AI-enablement.
• Master’s degree & 10 years of Quality, Operations, Product Development, Digital or related functions experience with demonstrated expertise in Digital Quality inclusive of AI-enablement.
• Bachelor’s degree & 12 years of Quality, Operations, Product Development, Digital or related functions experience with demonstrated expertise in Digital Quality inclusive of AI-enablement.
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Preferred Qualifications

• 8+ years of leadership experience managing leaders, matrix teams, complex programs, or enterprise transformations.
• Demonstrated GxP quality expertise and practical understanding of end-to-end quality execution processes across development and/or commercial operations.
• Experience leading or owning digital quality, workflow, or enterprise platform transformations, including experience adopting and governing the operational use of AI-enabled quality solutions.
• Deep understanding of GxP QMS / QMOS / QOM operating models and how to translate them into digital workflow platforms.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models where possible.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $263,692 - $322,290. Actual salary will vary based on several factors, including relevant skills, experience, and qualifications.