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. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With a 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 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.

In this 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 a 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 (e.g., event and issue management, audit/inspection management, document and knowledge, change control, supplier management, and other priority execution workflows).
• Partner across sites and functions to define process and technology requirements, including 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, including developing the organizational construct required to sustain this digital QMS evolution. Directionally, oversee a group of 10 to 15 professional staff from Sr. Director to Specialist level.
• 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, including operational execution of one or more workflows and the overall capabilities as the 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.

Key partnerships

• Quality Risk & System Governance: Receives control standards, escalation logic, governance requirements, and management review requirements; partners to embed them into platform workflows and evidence outputs.
• Digital Business Platform (Capability) Owner: Primarily owns business outcomes of a digital capability—defines the vision, priorities, operating model, and value realization while driving adoption.
• Head of Technology (Client-Facing Technology - IT): Primarily owns technology strategy & delivery—owns the technology strategy, architecture, engineering, and lifecycle management required to deliver secure, scalable, and AI-ready digital capabilities.
• Lead, AI & Data Science (Business): Primarily owns AI & analytics strategy and expertise—leads the AI, analytics, and data science capability by developing reusable models, insights, and AI solutions.
• Validation & Digital Assurance: Partners on CSA/CSV strategy, risk-based validation requirements, and inspection-ready lifecycle documentation while preserving independent assurance.
• Global Quality Operations functions: These groups support the execution of our development pipeline, launch, and in-line supply. The systems and processes enabled by this function are critical to the broader business strategy, ongoing inspection readiness, and project imperatives.

Requirements

• Basic 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, OR
  • 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, OR
  • 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 with strong proficiency in understanding GxP global regulations.
  • 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.
  • Experience as a senior business owner, product owner, or transformation leader for quality systems, content/document ecosystems, event management, or related platforms.
  • Strong understanding of inspection readiness optics, data integrity expectations, AI development and validation requirements, and evidence-generation requirements in digital environments.
  • Experience managing global teams and multi-year platform portfolios with measurable value realization.

Amgen leadership attributes include:

• Inspiration: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive.
• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection.
• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders.
• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results.

Benefits

Amgen offers a competitive 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 (or sales-based incentive plan for field sales representatives).
• 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.