Executive Director, Quality Systems GxP Platform Lead
New
A
AmgenBiotech Pharmaceuticals
United StatesFull-TimeExecutive
SalaryUSD 263692 - 322290 / year
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Job Details
- Experience
- Doctorate degree & 6 years, Master’s degree & 10 years, or Bachelor’s degree & 12 years of experience; 6 years of managerial experience.
- Required Skills
- Artificial Intelligence
Requirements
- Doctorate degree & 6 years, Master’s degree & 10 years, or Bachelor’s degree & 12 years of experience in Quality, Operations, Product Development, Digital, or related functions.
- Demonstrated expertise in Digital Quality inclusive of AI-enablement.
- 6 years of managerial experience directly managing people or leadership experience directing teams and resources.
- Strong proficiency in understanding GxP global regulations.
- Experience leading or owning digital quality, workflow, or enterprise platform transformations.
- Deep understanding of GxP QMS / QMOS / QOM operating models.
- Strong understanding of inspection readiness, data integrity, and AI validation requirements.
- Experience managing global teams and multi-year platform portfolios.
Responsibilities
- Operationalize the GxP Quality Operating Model vision and strategy.
- Own business strategy, funding, roadmap, and lifecycle governance for enterprise GxP quality execution platforms.
- Partner across functions to define control requirements, workflow needs, and user acceptance criteria.
- Drive the evolution from manual process-centric QMS toward platform-enabled, AI-orchestrated execution.
- Establish platform operating disciplines for release governance, health, and value realization.
- Lead adoption, process harmonization, and business readiness for deployed platforms.
- Define platform health metrics, operational KPIs, and ROI measures.
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