Global MES Delivery Lead — Manufacturing IT & Compliance

Regeneron Pharmaceuticals, Inc (USA); United States; Vor Ort; USD 108.000 - 206.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc (USA) seeks an MES Program Delivery Lead to drive end-to-end MES program delivery across IOPS sites, spanning design, build, validation, deployment, and post-live stabilization of capabilities such as electronic batch records and recipe/workflow management.

You will lead cross-functional teams including internal staff, system integrators, and vendors, manage release planning and budgeting, and collaborate with business owners to define scope, timelines, and

Qualifikationen

• Demonstrated SDLC and CSA methodologies in validated GxP systems.
• Experience delivering MES programs including electronic batch records, recipe management, and integrations with automation/SCADA, ERP, LIMS, and historian systems.
• Agile Scrum Master certification (CSM or PSM) preferred.
• Strong stakeholder management and communication skills; able to translate complex technical delivery status into clear narratives for executive audiences.
• Experience managing system integrators, vendor relationships, and cross-functional delivery teams in a regulated pharmaceutical or biotech environment preferred.
• BS/BA in Information Technology or a related field; equivalent combinations considered.
• Project Manager: 10+ years of delivery leadership in MES; Senior PM: 12 years; level determined by qualifications.

Aufgaben

• Own end-to-end MES program delivery across IOPS sites—design, build, validation, deployment, and post-go-live stabilization of MES capabilities.
• Lead cross-functional delivery teams including internal staff, system integrators, and vendors; manage release planning, sprint ceremonies, and resources across the program.
• Define MES program scope, roadmap, deliverables, and timelines with business owners and senior stakeholders; manage budgets and capacity.
• Identify, triage, and remove impediments; mitigate risks across the program.
• Ensure all MES deliverables meet GxP, ALCOA+, and 21CFR Part11 with SDLC/PMLC and CSA methodologies.
• Serve as central communication bridge; report on program performance vs schedule, budget, and quality targets.
• Ensure delivery and validation documentation is audit-ready; manage formal change control for scope changes.
• Lead and develop direct reports with regular performance feedback and training.

Kenntnisse

SDLC

CSA

GxP

Stakeholder mgmt

Agile Scrum

Vendor mgmt

Ausbildung

BS/BA in IT or related field

Tools

ERP systems

LIMS

SCADA

Historian systems

Jobbeschreibung

Regeneron Pharmaceuticals, Inc (USA) seeks an MES Program Delivery Lead to drive end-to-end MES program delivery across IOPS sites, spanning design, build, validation, deployment, and post-live stabilization of capabilities such as electronic batch records and recipe/workflow management.

You will lead cross-functional teams including internal staff, system integrators, and vendors, manage release planning and budgeting, and collaborate with business owners to define scope, timelines, and