Position Summary:
The Program Manager: Manufacturing Site Stand-Up is responsible for leading the end-to-end technology enablement of a new greenfield manufacturing facility i. This high-visibility program encompasses the deployment of all core manufacturing and quality systems – including SAP, PAS-X MES, laboratory systems (LIMS), quality management systems (QMS), and all manufacturing and quality IT applications – as well as the design and build-out of the site’s complete IT/OT hardware and infrastructure. The Program Manager coordinates across global project teams and functional streams to ensure the site is technology-ready for manufacturing operations on schedule and within budget. This is a senior leadership role requiring deep expertise in greenfield site technology deployments, enterprise system implementations, cross-functional coordination at a global scale, and program delivery within a regulated pharmaceutical manufacturing environment.
Requirements
Responsibilities:
- Own end-to-end program delivery for the technology stand-up of the manufacturing site, integrating all workstreams (SAP, PAS-X MES, quality systems, infrastructure, hardware, network, and security) into a unified program plan
- Develop and maintain the integrated master schedule with clear milestones, critical path analysis, and interdependencies across all technology workstreams and the broader site construction/commissioning timeline
- Selecting the appropriate project management methodology is selected for relevant projects (waterfall, agile or hybrid) to ensure optimal delivery outcomes for diverse project types
- Coordinate S/4 Hana / NextGen migration activities including module configuration (PP, MM, QM, WM/EWM, PM), master data migration, integration testing, cutover planning, and go-live support
- Oversee PAS-X MES SaaS migration in conjunction with MES Program Lead and manage local site activities data conversion, EBR setup, equipment integration, and validation for the Site site’s manufacturing processes
- Manage the deployment of all manufacturing and quality systems including LIMS, QMS (e.g., Veeva, TrackWise), document management systems, environmental monitoring systems, equipment qualification systems, and serialization/track-and-trace solutions
- Manage hardware procurement, delivery logistics, installation, and commissioning for all infrastructure components, coordinating with construction and facilities teams on space readiness, power, and cooling requirements
- Serve as the central coordination point between the site team and global functional teams (, Global Manufacturing, Global Quality, Global Supply Chain, Global Engineering) to ensure alignment on system standards, templates, and configurations
- Coordinate with global SAP and MES Centers of Excellence to leverage standard deployment templates, global master data governance, and validated system configurations
- Manage dependencies with other concurrent global programs (e.g., MES Program, NextGen ERP, x) to avoid conflicts, leverage synergies, and align timelines
- Facilitate cross-timezone collaboration across global project teams, implementation partners, and vendor organizations to maintain program momentum
- Ensure the Site deployment aligns with global architecture standards, cybersecurity policies, and enterprise technology roadmaps
- Ensure that the appropriate program governance processes and standards are followed, working closely with the PMO, ensuring full alignment with PMO methodologies, governance, tools and templates
- Prepare and facilitate compliance stage gate documentation, reviews, and relevant approvals across all technology workstreams
- Maintain and control the integrated business requirements document (program scope) with rigorous change control across all workstreams
- Prepare weekly program status reports, executive dashboards, and steering committee materials consolidating progress across all workstreams
- Establish the appropriate program meeting cadence and lead weekly PMO meetings with all relevant stakeholders
- Proactively identify and assess program risks across all workstreams, including construction-technology dependencies, system integration risks, resource contention across global teams, vendor delivery risks, and regulatory readiness gaps
- Coordinate risk tracking, mitigation planning, and issue resolution, escalating through the appropriate PMO escalation process
- Manage program financials across all technology workstreams, including consolidated budget tracking, periodic forecasting updates, variance analysis, and capital vs. operational expenditure management
- Anticipate roadblocks, respond to changes in the site construction timeline, and escalate issues when needed to PMO leadership
- Coordinate Computer System Validation (CSV) activities across all GxP systems (SAP, PAS-X, LIMS, QMS), ensuring compliance with GAMP 5 guidelines, 21 CFR Part 11, and EU Annex 11 requirements
- Partner with Quality Assurance to ensure all manufacturing and quality systems meet regulatory requirements for site licensing and inspection readiness
- Ensure GxP data integrity (ALCOA+ principles) across all system deployments and integrations
- Coordinate with site qualification teams to align system validation timelines with equipment qualification (IQ/OQ/PQ) and process validation schedules
- Ensure that integration testing, data verification testing, user testing, and other relevant testing activities are executed, with appropriate evidence recorded as required
- Develop integrated cutover plans across all technology workstreams, sequencing system go-lives to align with the site’s phased manufacturing ramp-up schedule
- Plan and execute hypercare support periods for each system go-live, ensuring manufacturing readiness and rapid defect resolution
- Ensure that a smooth knowledge transfer to Site site BAU IT operations and support teams is completed in a timely and organized manner, including coordination of documentation, stakeholder training, system walkthroughs, and operational runbooks for all deployed systems
Stakeholder Collaboration:
- Foster strong relationships and ensure stakeholder alignment on priorities and deliverables across: Leadership, Site Leadership (Site), Global IT Leadership, Global Manufacturing & Quality Leadership, Delivery Leads, Implementation Managers, construction/facilities teams, Business Partners, project team members, implementation partners, and key stakeholders from the PMO & Finance
- Engage with system integrators, hardware vendors, and implementation partners to drive accountability and performance within program timelines
- Facilitate effective communication with stakeholders at all organizational levels, from site engineers and operators to senior leadership
- Serve as the single point of accountability for technology readiness reporting to the broader Site stand-up steering committee
Education and Experience:
- Bachelor’s degree in Engineering, Computer Science, Information Systems, or a related field; Master’s degree preferred
- PMP certification required; SAFe, Agile Scrum Master, or Prince2 certifications are a plus
- 12+ years of progressive experience in IT program management within pharmaceutical, biotech, or similarly regulated manufacturing environments
- Demonstrated experience leading greenfield manufacturing site technology stand-ups or large-scale multi-system implementations
- Strong SAP implementation experience (preferably S/4HANA) including manufacturing and quality modules (PP, QM, MM, WM/EWM, PM)
- Experience with MES platforms (PAS-X strongly preferred) including EBR, recipe management, and equipment integration
- Proven track record of managing complex, multi-workstream programs with global coordination requirements
- Experience managing IT/OT infrastructure deployments including data center, network, and end-user computing build-outs
- Strong understanding of Computer System Validation (CSV), GAMP 5 guidelines, 21 CFR Part 11 / EU Annex 11 requirements, and pharmaceutical site licensing processes
- Experience in waterfall, agile & hybrid methodologies
Knowledge, Skills, Ability Requirements:
- Deep knowledge of pharmaceutical manufacturing systems landscape: SAP, MES, LIMS, QMS, DMS, environmental monitoring, serialization, and equipment integration
- Strong understanding of IT/OT infrastructure design for manufacturing environments, including network architecture, cybersecurity, and data center operations
- Experience in pharma () space with expert knowledge of GxP compliance, manufacturing processes, and supply chain complexities
- Ability to manage complex stakeholder landscapes spanning local site teams, global functional teams, and multiple external partners concurrently
- Strong grasp of finance principles including multi-year budget forecasting, capital planning, variance analysis, and financial reporting within IT organizations
- Proven ability to effectively communicate with colleagues at all levels within the organization
- Must be willing and able to work independently and handle simultaneous tasks
- Attention to detail with the ability to view the larger picture
- Consistently model behaviors of accountability and ownership through excellent interpersonal, communication, negotiation, and group facilitation skills
- Ability to tailor communication to technical teams, executives, and end-users
- High level of competency using Microsoft Office suite – Excel, Microsoft Project, PowerPoint, PowerBI (or SQL Server Reporting Services) with experience using Microsoft Project Server and/or other portfolio management tools
Travel Requirements:
10–15% travel required, with potential periods of higher travel intensity during key deployment phases.
