Global MES Program Delivery Lead

Regeneron Pharmaceuticals; City of Troy (NY); Sur place; USD 108 000 - 206 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals in Troy, NY is seeking an MES Program Delivery Lead to drive end-to-end MES initiatives across IOPS sites, coordinating cross-functional teams, system integrators, and business stakeholders to deliver compliant MES capabilities.

The role covers design, build, validation, deployment, and post-go-live stabilization of MES, including electronic batch records, recipe/workflow management, and system integrations, while ensuring adherence to GxP and CSA standards.

Qualifications

• Must have strong stakeholder management and communication skills.
• Experience leading cross-functional delivery teams and external vendors.
• Familiarity with MES, SDLC/CSA, and regulatory compliance (GxP, 21 CFR Part 11).
• May consider equivalent combination of education and experience; level determined by qualifications.

Responsabilités

• Own end-to-end MES program delivery across IOPS sites — design, build, validation, deployment, and post-go-live support.
• Lead cross-functional delivery teams including internal staff, system integrators, and vendors; manage release planning and resources.
• Define MES program scope, roadmap, deliverables, and timelines with business owners and senior stakeholders.
• Proactively identify, triage, and remove impediments; mitigate technical, operational, delivery, and compliance risks.
• Ensure all MES deliverables meet GxP, ALCOA+, and 21 CFR Part 11 requirements using SDLC/CSA methodologies.
• Serve as primary communication bridge; report on program performance against schedule, budget, and quality targets.
• Ensure documentation is audit-ready; manage formal change control for scope changes.
• Lead and develop team members with monthly performance feedback and training growth.

Connaissances

Stakeholder management

Cross-functional leadership

Agile / Scrum Master

Effective communication

Regulatory delivery

Formation

BS/BA in Information Technology or related field

Description du poste

Regeneron Pharmaceuticals in Troy, NY is seeking an MES Program Delivery Lead to drive end-to-end MES initiatives across IOPS sites, coordinating cross-functional teams, system integrators, and business stakeholders to deliver compliant MES capabilities.

The role covers design, build, validation, deployment, and post-go-live stabilization of MES, including electronic batch records, recipe/workflow management, and system integrations, while ensuring adherence to GxP and CSA standards.