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Amgen

#WeareBiotech

Executive Director, GxP Quality Systems Platform

ExecutiveExecutiveFull TimeRemoteLeadTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

5 days ago

Salary

$263.7K - $322.3K / year

Seniority

Lead

No structured requirement data.

Job Description

Executive Director, GxP Quality Systems Platform

Amgen

Role Description Join Amgen’s Mission of Serving Patients. 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. - 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 translate process and technology requirements into measurable business outcomes. - Drive the evolution from process-centric Quality Management System (QMS) operations toward platform-enabled quality execution. - 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. - Define platform health metrics, operational KPIs, and value measures tied to quality, compliance, speed, user experience, and ROI. - Ensure platforms are designed and operated to support 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. 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. Requirements - 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. - 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. - Experience managing global teams and multi-year platform portfolios with measurable value realization. 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, or for field sales representatives, a sales-based incentive plan. - Stock-based long-term incentives. - Award-winning time-off plans and bi-annual company-wide shutdowns. - Flexible work models where possible.

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