MES Program Delivery Lead - Senior Manager

About the role

Join our IOPS IT team as a MES Program Delivery Lead, driving the end-to-end delivery of our Manufacturing Execution System (MES) program across global manufacturing sites. You will align cross-functional teams, system integrators, and business stakeholders to deliver MES capabilities that are on scope, on schedule, and fully compliant.

Responsibilities

• 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

Requirements

• 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

Qualifications

• BS/BA in Information Technology or a related field
• 8+ years of experience in delivery leadership, program/project management, or IT management
• 10+ years of experience in delivery leadership, program/project management, or IT management