Portfolio Manager MES & Digital Manufacturing
Remote (Travel as Required)
Project Overview
We are seeking an experienced Portfolio Manager to lead a portfolio of strategic
Manufacturing Execution System (MES) and Digital Manufacturing initiatives within
the Life Sciences industry. This role is responsible for managing multiple programs and
projects across manufacturing sites, ensuring successful delivery of digital
transformation initiatives that improve manufacturing efficiency, product quality,
regulatory compliance, and operational excellence.
The ideal candidate will possess a strong background in pharmaceutical or life sciences
manufacturing, digital manufacturing technologies, MES implementations, and
enterprise program management. This role requires close collaboration with business
stakeholders, manufacturing operations, quality, IT, validation, and external
implementation partners to deliver scalable and compliant manufacturing solutions.
Key Responsibilities
Portfolio Management
Manage and govern a portfolio of MES and Digital Manufacturing programs
across multiple manufacturing sites.
Define portfolio strategy, roadmap, priorities, budgets, and resource allocation.
Monitor portfolio health, delivery milestones, risks, dependencies, and financial
performance.
Establish governance frameworks, executive reporting, and KPI dashboards.
Ensure alignment of manufacturing digital initiatives with organizational business
objectives.
Program & Project Leadership
Lead cross-functional teams responsible for MES implementation, upgrades, and
digital transformation initiatives.
Manage multiple concurrent projects from planning through deployment and
hypercare.
Drive project planning, scheduling, budgeting, vendor management, and
executive communications.
Resolve cross-program risks, issues, and resource conflicts.
Business & Stakeholder Management
Partner with Manufacturing, Quality, Engineering, Supply Chain, Validation, and
IT leadership.
Facilitate executive steering committee meetings and provide regular portfolio
status updates.
Build strong relationships with site leadership and global business stakeholders.
Drive organizational change management and user adoption initiatives.
Digital Manufacturing Leadership
Lead initiatives involving Manufacturing Execution Systems (MES),
Manufacturing Operations Management (MOM), and Smart Manufacturing.
Support manufacturing digitalization initiatives including automation, paperless
manufacturing, electronic batch records, manufacturing analytics, and Industry
4.0 capabilities.
Promote standardization and harmonization of manufacturing processes across
global sites.
Compliance & Quality
Ensure solutions comply with Life Sciences regulatory requirements including:
o GxP
o FDA 21 CFR Part 11
o EU Annex 11
o GAMP 5
o Computer Software Assurance (CSA)
Support validation planning and ensure regulatory readiness for manufacturing
systems.
Financial & Vendor Management
Manage portfolio budgets, forecasts, and financial reporting.
Oversee system integrators, implementation partners, and software vendors.
Track value realization and return on investment (ROI) across manufacturing
initiatives.
Required Qualifications
Bachelor's degree in Engineering, Information Technology, Computer Science,
Life Sciences, or a related discipline.
12+ years of IT and Digital Transformation experience.
5+ years managing enterprise portfolios or large programs focused on MES and
Digital Manufacturing.
5+ years of proven experience delivering multiple global manufacturing
technology initiatives.
5+ years of strong experience within the Life Sciences, Pharmaceutical,
Biotechnology, or Medical Devices industry.
5+ years of experience managing global cross-functional teams and complex
stakeholder environments.
Required Technical & Functional Expertise
Manufacturing Execution Systems (MES)
Digital Manufacturing & Manufacturing Operations Management (MOM)
Smart Manufacturing / Industry 4.0
Electronic Batch Records (EBR)
Manufacturing Process Digitalization
Manufacturing Systems Integration
Program & Portfolio Management
Agile and Waterfall delivery methodologies
Vendor & Budget Management
Executive Stakeholder Management
Risk and Governance Management
Preferred Experience
Experience with one or more of the following platforms:
Werum PAS-X
Rockwell PharmaSuite
Siemens Opcenter Execution Pharma
Emerson Syncade
Krber PAS-X
SAP Manufacturing Integration & Intelligence (SAP MII)
SAP Digital Manufacturing
Aveva Manufacturing Execution Systems
Preferred Certifications
PMP or PgMP
PMI Portfolio Management Professional (PfMP)
SAFe Program Consultant (SPC) or SAFe Agilist
ITIL Foundation
Lean Six Sigma Green Belt or Black Belt
Key Skills
Portfolio Management
Program Management
MES
Digital Manufacturing
Manufacturing Operations Management (MOM)
Life Sciences
Pharmaceutical Manufacturing
GxP
FDA 21 CFR Part 11
GAMP 5
CSA
Electronic Batch Records (EBR)
Industry 4.0
Smart Manufacturing
Executive Stakeholder Management
Budget & Financial Management
Risk & Governance
Vendor Management
Agile Delivery
Manufacturing Digital Transformation
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