Program Manager - MES

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Job Title: IT Program Manager - Manufacturing Execution System (M.E.S)

Job Description

Location : Greenville , NC

Duration : Long term

The MES IT Program Manager is responsible for leading the strategy, planning, implementation, and ongoing evolution of Manufacturing Execution System programs across life sciences manufacturing sites. This role partners with Manufacturing, Quality, Engineering, Supply Chain, Automation, and IT teams to deliver compliant, reliable, and scalable digital manufacturing solutions.

The Program Manager oversees complex, multi-site MES initiatives from business case development through deployment, validation, adoption, and operational handover. The role ensures that MES solutions support business objectives, regulatory requirements, data integrity principles, and standardized manufacturing processes.

Key Responsibilities

Program Leadership

·                  Develop and maintain the MES program strategy, roadmap, governance model, budget, resource plan, and implementation schedule.

·                  Lead global or regional MES deployments across pharmaceutical, biotechnology, medical-device, or contract manufacturing sites.

·                  Manage multiple interdependent projects, workstreams, vendors, and site deployment teams.

·                  Establish program objectives, success measures, decision-making forums, reporting standards, and escalation processes.

·                  Track program scope, milestones, costs, risks, issues, dependencies, and benefits realization.

·                  Provide clear status reporting and recommendations to executive sponsors and governance committees.

·                  Ensure effective transition from project delivery to application support and business operations.

Business and Technology Alignment

·                  Partner with Manufacturing, Quality, Engineering, Automation, Supply Chain, and IT leaders to define business requirements and implementation priorities.

·                  Translate manufacturing and compliance needs into scalable MES capabilities and technical roadmaps.

·                  Promote standardized processes, master data, system configuration, interfaces, and deployment methodologies across sites.

·                  Balance global template requirements with justified site-specific and product-specific needs.

·                  Support the selection and implementation of MES platforms and associated technologies.

·                  Ensure alignment between MES and related systems, including ERP, laboratory systems, quality systems, historians, data platforms, warehouse systems, and automation controls.

Regulatory Compliance and Quality

·                  Ensure MES implementations comply with applicable regulatory and quality requirements, including GxP, Good Manufacturing Practice, data integrity, electronic records, and electronic signatures.

·                  Partner with Quality and Validation teams to define and execute computer system validation and assurance strategies.

·                  Ensure requirements, risk assessments, testing, traceability, release documentation, and operational procedures are complete and inspection-ready.

·                  Embed security, auditability, access control, segregation of duties, backup, recovery, and business continuity requirements into the solution.

·                  Support regulatory inspections, customer audits, and internal quality reviews related to MES systems and processes.

·                  Ensure changes are managed through approved quality and IT change-control processes.

Delivery and Deployment

·                  Lead the end-to-end delivery lifecycle, including discovery, process design, requirements, configuration, integration, testing, validation, training, cutover, hypercare, and stabilization.

·                  Develop site-readiness assessments and deployment plans covering infrastructure, data, equipment integration, procedures, training, support, and organizational change.

·                  Coordinate production schedules and cutover activities to minimize operational disruption.

·                  Define and monitor release-management, defect-management, and environment-management processes.

·                  Ensure solutions meet performance, availability, scalability, supportability, and cybersecurity expectations.

·                  Apply lessons learned and reusable assets to improve the speed, quality, and predictability of future deployments.

Stakeholder and Change Management

·                  Build strong relationships with site leadership, manufacturing users, quality representatives, technical teams, and executive sponsors.

·                  Lead organizational change-management activities to support adoption of new digital manufacturing processes.

·                  Communicate program impacts, decisions, risks, and expected benefits to technical and nontechnical audiences.

·                  Ensure impacted employees receive appropriate role-based training and implementation support.

·                  Address stakeholder concerns and resolve conflicts involving priorities, scope, resources, and solution design.

·                  Champion harmonized business processes and sustainable system ownership.

Vendor and Financial Management

·                  Manage MES software vendors, systems integrators, consultants, and other delivery partners.

·                  Define statements of work, deliverables, service expectations, acceptance criteria, and performance measures.

·                  Monitor vendor quality, schedule adherence, staffing, costs, and contractual commitments.

·                  Manage program budgets, forecasts, purchase orders, capital expenditures, and operating expenses.

·                  Identify opportunities to improve delivery efficiency, licensing costs, support models, and total cost of ownership.

Skill

• Demonstrated experience managing large, complex, cross-functional programs with multiple sites, workstreams, and external partners. • Experience implementing or supporting Manufacturing Execution Systems in a regulated manufacturing environment. • Strong understanding of pharmaceutical, biotechnology, or medical-device manufacturing processes. • Working knowledge of GxP, computer system validation or assurance, data integrity, electronic records, and regulated change control. • Experience with system integration, master data, manufacturing automation, and enterprise application landscapes. • Strong program-management skills, including planning, budgeting, risk management, governance, and executive reporting. • Excellent communication, facilitation, negotiation, and stakeholder-management skills. • Ability to work effectively across business, quality, manufacturing, and technical organizations.