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Job Description
 

The Director, Global MES Business Lead is a senior, business-facing leadership role accountable for defining, governing, and scaling the Manufacturing Execution System (MES) strategy across the global manufacturing network. This role serves as the primary bridge between Global Manufacturing, Quality, Technical Development, MSAT/Process Engineering/Automation, and IT to ensure MES platforms and business processes enable compliant, efficient, and digitally enabled operations across all sites.

At the Director level, this role owns the global MES product and business process vision and roadmap and is accountable for translating enterprise manufacturing and quality strategies into executable, scalable MES capabilities. The role emphasizes strong business ownership, cross-functional leadership, and operational value delivery, while partnering closely with IT and site teams for technical execution.

KEY RESPONSIBILITIES

Global MES Strategy & Product Ownership

• Define and maintain the global MES strategy, roadmap, and operating model, aligned with enterprise manufacturing, quality, and digital transformation objectives.
• Serve as the global business owner for MES and electronic batch records, accountable for platform direction, lifecycle management, and business value realization across sites.
• Establish and govern global MES standards, design principles, templates, and best practices for MES/EBR implementation and sustainment.
• In partnership with Quality, develop and maintain standards and best practices for Electronic Batch Record review, including approaches and expectations for Review by Exception.
• Own prioritization of MES capabilities, enhancements, and site demands, balancing compliance, operational value, risk, and scalability.

Business Partnership & Stakeholder Leadership

• Act as the primary MES business partner to Global Manufacturing, IT, Site Operations/Automation, Quality, Technical Development, and Supply Chain organizations.
• Translate manufacturing and quality needs into clear MES requirements, capabilities, and delivery roadmaps.
• Chair or contribute to cross-functional MES governance forums (e.g. Manufacturing Digital Council – MDC) to drive alignment, standard adoption, and timely decision-making.
• Represent MES in manufacturing, digital, and quality leadership forums as a trusted subject matter and business advisor.

MES Delivery, Lifecycle & Operations

• Provide business oversight for global MES delivery models, including build, deployment, validation, and sustainment in regulated (GxP) environments.
• Ensure consistent, compliant approaches to MES change management, risk assessment, issue resolution, deviations, and CAPA execution.
• Partner with IT/OT leadership to define and sustain effective run-and-build support models, vendor strategies, and service ownership.
• Guide MES deployment strategies for new facilities, expansions, tech transfers, and major process changes.

Compliance, Quality & Data Integrity

• Ensure MES solutions meet global GMP, data integrity, validation, and regulatory expectations.
• Support health authority inspections, internal audits, and regulatory engagements related to MES and electronic batch records.
• Embed compliance-by-design and data integrity principles into MES standards, processes, and operating models.

Digital Enablement & Continuous Improvement

• Enable digital manufacturing capabilities through MES, including integration