Description

Key Responsibilities

Program Leadership

• Lead end-to-end delivery of MES and Digital Manufacturing programs across multiple manufacturing sites.
• Define the program roadmap, scope, objectives, milestones, delivery approach, and success measures.
• Manage multiple related projects, workstreams, and dependencies under the overall program.
• Ensure alignment between program deliverables, business objectives, and enterprise digital manufacturing strategy.
• Establish program governance, decision-making forums, and escalation processes.

MES and Digital Manufacturing Delivery

• Manage MES implementation, upgrade, rollout, migration, and optimization initiatives.
• Support manufacturing digital transformation capabilities such as:
  • Electronic Batch Records
  • Paperless Manufacturing
  • Manufacturing Operations Management
  • Production Scheduling
  • Work Instructions
  • Material Tracking
  • Equipment Integration
  • Manufacturing Analytics
  • Review by Exception
• Coordinate integration of MES with SAP or ERP, LIMS, QMS, SCADA, PLC, historians, warehouse systems, and other manufacturing applications.
• Drive process standardization and solution harmonization across global manufacturing sites.

Program Planning and Execution

• Develop and maintain integrated program plans, schedules, budgets, resource plans, and delivery forecasts.
• Track milestones, critical paths, risks, issues, assumptions, and dependencies.
• Coordinate business, functional, technical, validation, infrastructure, cybersecurity, and deployment teams.
• Ensure timely completion of design, configuration, integration, testing, validation, cutover, deployment, and hypercare activities.
• Manage program changes through formal scope and change-control processes.

Stakeholder Management

• Partner with Manufacturing, Quality, Engineering, IT, Validation, Supply Chain, and site leadership.
• Facilitate steering committee meetings, governance reviews, and executive status discussions.
• Provide clear reporting on program health, delivery progress, financials, risks, decisions, and business outcomes.
• Build alignment across global and site-level stakeholders.
• Manage expectations and resolve conflicts across business, technology, and vendor teams.

Risk, Quality, and Compliance

• Ensure program delivery complies with applicable Life Sciences standards and regulations, including:
  • GxP
  • FDA 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • ALCOA+ data integrity principles
  • Computer System Validation
  • Computer Software Assurance
• Partner with Quality and Validation teams to ensure proper documentation, traceability, testing, and approval.
• Support inspection readiness, audit requests, and remediation activities.
• Proactively identify and mitigate delivery, compliance, operational, and technical risks.

Financial and Vendor Management

• Manage program budgets, forecasts, purchase orders, contracts, and financial performance.
• Oversee system integrators, software vendors, consultants, and managed service providers.
• Monitor vendor milestones, deliverables, service levels, and contractual commitments.
• Manage Statements of Work, resource capacity, and commercial dependencies.
• Track program benefits, operational improvements, and value realization.

Change Management and Adoption

• Drive organizational readiness, communication, training, and user-adoption activities.
• Coordinate site readiness assessments, deployment planning, cutover, and hypercare.
• Work with business process owners to ensure new processes and systems are effectively adopted.
• Monitor post-deployment performance and support transition to operations.

Required Qualifications

• Bachelor's degree in Engineering, Information Technology, Computer Science, Life Sciences, or a related discipline.
• 10 15+ years of overall experience in IT, manufacturing systems, digital transformation, or program management.
• At least 5 years of experience managing large MES or Digital Manufacturing programs.
• 5+ years of strong experience in the Pharmaceutical, Biotechnology, Medical Devices, or broader Life Sciences industry.
• 5+ years of proven experience leading global or multi-site technology implementations.
• 5+ years of demonstrated ability to manage complex programs involving business, technology, validation, and vendor teams.
• 5+ years of strong understanding of regulated manufacturing environments and system lifecycle requirements.

Required Functional and Technical Expertise

• Manufacturing Execution Systems
• Digital Manufacturing
• Manufacturing Operations Management
• Electronic Batch Records
• Paperless Manufacturing
• Manufacturing Systems Integration
• Program and Project Management
• GxP and Computer System Validation
• Multi-site Deployment
• Vendor and Financial Management
• Executive Stakeholder Management
• Risk and Dependency Management
• Organizational Change Management

Preferred Platform Experience

Experience with one or more of the following is preferred:

• K rber Werum PAS-X
• Rockwell Automation PharmaSuite
• Siemens Opcenter Execution Pharma
• Emerson Syncade
• SAP Digital Manufacturing
• SAP MII
• AVEVA MES
• FactoryTalk ProductionCentre
• Ignition
• Manufacturing historians and SCADA platforms

Preferred Certifications

• PMP
• PgMP
• SAFe Agilist or SAFe Program Consultant
• ITIL Foundation
• Lean Six Sigma Green Belt or Black Belt
• Agile or Scrum certification

Key Skills

• Program Management
• MES
• Digital Manufacturing
• Manufacturing Operations Management
• Electronic Batch Records
• Paperless Manufacturing
• Life Sciences
• Pharmaceutical Manufacturing
• GxP
• FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5
• CSV
• CSA
• SAP Integration
• LIMS and QMS Integration
• Multi-site Deployment
• Executive Stakeholder Management
• Vendor Management
• Budget Management
• Risk Management
• Change Management
• Digital Transformation

Key Skills

Education

Bachelor's degree