Description

Lead end-to-end delivery of Manufacturing Execution System (MES) and Digital Manufacturing programs across multiple global sites, ensuring alignment with business objectives and enterprise strategy.

This role is remote.

Responsibilities

• Define program roadmaps, scope, milestones, and success measures for MES implementations, upgrades, and optimizations.
• Manage integrated program plans, including budgets, resource allocation, schedules, and delivery forecasts.
• Coordinate cross-functional teams (IT, Validation, Quality, Engineering) and external vendors to drive delivery and resolve dependencies.
• Establish governance frameworks, escalation processes, and steering committee reporting for program health and risk management.
• Ensure compliance with Life Sciences regulations (GxP, FDA 21 CFR Part 11, GAMP 5) and manage change control and adoption activities.

Required Skills

• 10+ years of overall experience in IT, manufacturing systems, or program management.
• 5+ years managing large-scale MES or Digital Manufacturing programs in the Pharmaceutical, Biotechnology, or Medical Devices sectors.
• Deep knowledge of MES integration with SAP/ERP, LIMS, QMS, SCADA, PLC, and historians.
• Strong proficiency in Program Management methodologies (PMP, SAFe, Agile).
• Experience with Computer System Validation (CSV) and data integrity principles (ALCOA+).
• Proven ability to manage vendor relationships, contracts, and financial performance.
• Bachelor's degree in Engineering, IT, Computer Science, Life Sciences, or related discipline.

Preferred Skills

• Experience with paperless manufacturing, electronic batch records, and manufacturing analytics.
• Background in driving organizational change management and user adoption strategies.

Key Skills

Education

Bachelor's degree