MES Delivery Lead - Global Sites (GxP/CSA)

Regeneron Pharmaceuticals; United States; On-site; USD 108,000 - 206,000; Full time

Job summary

Regeneron Pharmaceuticals seeks a MES Program Delivery Lead to drive end-to-end MES delivery across global sites, coordinating cross-functional teams, integrators, and vendors with a focus on compliant, on-schedule delivery.

The role involves defining scope and roadmap, managing budgets, mitigating risks, and ensuring CSA/SDLC adherence for electronic batch records and integrations with ERP/LIMS/SCADA.

Qualifications

• BS/BA in Information Technology or related field.
• Project Manager: 10+ years of delivery leadership experience for MES platforms.
• Senior Project Manager: 12+ years in delivery leadership for MES platforms.
• May consider an equivalent combination of education and experience.

Responsibilities

• Own end-to-end MES program delivery across IOPS sites.
• Lead cross-functional delivery teams incl. staff, integrators & vendors.
• Define MES scope, roadmap, deliverables, and timelines.
• Manage budgets, workload balancing, and capacity planning.
• Identify and mitigate risks across the program.
• Ensure GxP, ALCOA+, 21 CFR Part 11 compliance via CSA/SDLC.
• Maintain audit-ready documentation and change controls.
• Report program status to executives with schedule, budget, quality updates.

Skills

MES program delivery

Cross-functional leadership

SDLC/CSA

GxP compliance

Agile Scrum Master

Education

BS/BA in Information Technology or related field

Tools

ERP integrations

LIMS integrations

SCADA integrations

Job description

Regeneron Pharmaceuticals seeks a MES Program Delivery Lead to drive end-to-end MES delivery across global sites, coordinating cross-functional teams, integrators, and vendors with a focus on compliant, on-schedule delivery.

The role involves defining scope and roadmap, managing budgets, mitigating risks, and ensuring CSA/SDLC adherence for electronic batch records and integrations with ERP/LIMS/SCADA.