Executive Director, GxP Quality Systems Platform

Job description

Career CategoryQualityJob 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 interfaces: The need to understand the overarching business strategy in R&D and Operations is paramount to working with and aligning with other critical programs and their interdependencies and needs for the QMS platform work and delivering in tandem to drive business results. This role will have critical groups it engages with that together aim at delivering the integrated GxP QOM vision and strategy as follows: 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 - owns the end-to-end business digital capability, defining the vision, priorities, operating model, and value realization while driving the 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 that enable the business vision. 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 that accelerate business transformation and decision-making. 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 enablement of the broader business strategy, on-going inspection readiness, and project imperatives. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The executive candidate we seek is an experienced leader with the following qualifications. 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 AND 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 so