Role Overview
We are seeking a high-caliber Senior Program Manager to lead a multi-year, enterprise-wide Manufacturing Execution System (MES) transformation. Our client is a leading global pharmaceutical organization that is digitizing their manufacturing footprint to drive compliance, reduce cycle times, and unlock real-time operational insights.
In this role, you will be the strategic quarterback and execution lead, orchestrating the rollout of our global MES template across multiple international manufacturing sites. You will bridge the gap between global IT, Engineering, Quality, and local site leadership to ensure harmonization, standard work processes, and seamless digital integration.
Key Responsibilities
- Global Program Orchestration: Define, launch, and execute the end-to-end MES transformation roadmap. Manage program scope, multi-million-dollar budgets, resources, and critical path timelines.
- Site Deployment & Harmonization: Partner with global template designers and local site deployment teams to drive standard recipe design, master data readiness, and system integration (integrating MES with ERP/SAP, LIMS, and automation layer/SCADA systems).
- Stakeholder & Change Management: Serve as the primary liaison between corporate leadership, steering committees, and site-level operations. Drive organizational change management (OCM) to ensure high adoption rates and minimal disruption to ongoing manufacturing.
- Regulatory & Quality Compliance: Ensure all system designs, validation protocols, and deployment activities comply with global health authority regulations (FDA 21 CFR Part 11, EudraLex Annex 11) and GAMP 5 computer system validation (CSV) standards.
- Vendor & Partner Management: Manage strategic relationships with MES software vendor (OpsTrakker) and system integration partners. Ensure delivery against SOWs and SLAs.
- Risk Mitigation: Proactively identify, track, and mitigate program-level risks, particularly around site readiness, data migration, and resource constraints.
Required Qualifications
- Experience: 10+ years of technical program management experience, with at least 5+ years leading large-scale MES or Digital Shop Floor implementations within a highly regulated manufacturing environment.
- Domain Expertise: Deep understanding of life sciences manufacturing processes (primary, secondary, packaging) and ISA-95/ISA-88 standards.
- Technical Literacy: Familiarity with major MES platforms (esp. OpsTrakker) and their integration touchpoints with SAP (ERP) and automation layers.
- Compliance Knowledge: Proven track record delivering systems within a validated, GxP-compliant framework. Strong grasp of CSV, GAMP 5, and data integrity principles.
- Leadership Style: Exceptional communication and negotiation skills. A proven "bridge-builder" who can align corporate digital strategies with practical, day-to-day site realities.
- Education: Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field. PMP, Agile/SAFe, or PgMP certifications are highly desirable.
What Will Make You Stand Out
- Experience managing a global template roll-out.
- Hands-on experience with modern cloud-hybrid MES architectures or transitioning legacy on-premise systems to SaaS/PaaS manufacturing platforms.
- A strong point of view on how MES coordinates with Advanced Analytics and IoT to create a true "Smart Factory.
