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 with automation systems, historians, ERP, and analytics platforms.
- Drive standardization and harmonization of manufacturing workflows while supporting site-specific operational needs.
- Leverage MES data to support operational excellence initiatives such as right-first-time execution, cycle time reduction, and data-driven decision making.
Leadership & Organizational Effectiveness
- Lead and influence global, matrixed teams across Manufacturing, Quality, Engineering, and IT without direct line authority.
- Build strong partnerships with site leaders, IT delivery teams, and external technology partners.
- Drive organizational change management to support MES adoption, standardization, and maturity across the network.
Qualifications & Experience
Required Experience
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
- 12+ years of experience in pharmaceutical or biotech manufacturing environments with significant experience in MES/EBR systems.
- Proven experience leading multi-site or global MES initiatives in regulated (GxP) environments.
- Strong understanding of Global Manufacturing, process engineering fundamentals, and GMP requirements.
Preferred Experience
- Experience with leading MES platforms (e.g., Werum PAS-X or equivalent) and integration to automation, historians, and ERP systems.
- Experience supporting inspections, audits, deviations, and change control related to MES.
- Experience across one or more modalities (e.g., biologics, cell therapy, API, OSD).
- Demonstrated success influencing cross-functional, matrixed global teams.
Key Competencies
- Strong business and operational acumen with the ability to connect MES capabilities to manufacturing and quality outcomes.
- Excellent stakeholder influence and communication skills, including engagement with site and functional leaders.
- Ability to translate complex technical concepts into clear, actionable business language.
- Structured problem-solving, prioritization, and decision-making in complex, regulated environments.
- Comfort operating at the intersection of Manufacturing, Quality, and IT/OT.
What Success Looks Like
- A clear, pragmatic global MES strategy that is adopted by sites and functions.
- Improved consistency, compliance, and speed-to-value across MES implementations.
- Strong partnership and credibility with Manufacturing, Quality, and IT stakeholders globally.
- MES positioned as a foundational enabler for digital manufacturing and data-driven operations.
