Senior 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

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a MES Program Delivery Lead to join our IOPS IT team, driving end-to-end delivery of our Manufacturing Execution System program across our global manufacturing sites. In this role, you will serve as a servant-leader and strategic problem-solver — aligning cross-functional teams, system integrators, and business stakeholders to deliver MES capabilities that are on scope, on schedule, and fully compliant — while collaborating with Manufacturing, Quality, Automation, and IT functions. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Troy, New York, United States

• Work model: Monday - Friday 8am - 4:30pm, onsite

• Travel percentage: 10 - 20% to Ireland

Discover your role:

• Own end-to-end MES program delivery across IOPS sites — spanning solution design, build, validation, deployment, and post-go-live stabilization of capabilities including electronic batch records, recipe and workflow management, and system integrations

• Lead and direct cross-functional delivery teams including internal staff, system integrators, and vendors; manage release planning, sprint ceremonies, dependencies, and resource allocation across the program

• Partner with business owners and senior stakeholders to define MES program scope, roadmap, deliverables, and timelines; manage budgets, workload balancing, and capacity planning

• Proactively identify, triage, and remove impediments; spot and mitigate technical, operational, delivery, and compliance risks across the program

• Ensure all MES deliverables meet GxP, ALCOA+, and 21 CFR Part 11 requirements by effectively applying SDLC/PMLC and Computer Software Assurance (CSA) methodologies

• Serve as the central communication bridge between business owners, executives, vendors, and the delivery team — reporting on program performance against schedule, budget, and quality targets

• Ensure delivery and validation documentation is complete, audit-ready, and stored appropriately; manage formal change control for any scope changes

• Lead and develop direct reports through monthly performance feedback meetings, ensuring training requirements are met and team capabilities continue to grow

• Demonstrated experience applying SDLC and Computer Software Assurance (CSA) methodologies, including risk-based approaches to validation of GxP computerized systems

• Experience delivering MES programs including electronic batch records, recipe management, and integrations with automation/SCADA, ERP, LIMS, and historian systems preferred

• 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

This role requires:

• BS/BA in Information Technology or a related field

• Project Manager: 10+ years of experience in delivery leadership, program/project management, or IT management supporting MES platforms

• Senior Project Manager: 12 years of experience in delivery leadership, program/project management, or IT management supporting MES platforms

• May consider equivalent combination of education and experience; level determined based on qualifications

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$108,000.00 - $206,100.00