We are seeking a Senior IT Project Manager to lead the implementation and rollout of a Manufacturing Execution System (MODA ES) with a focus on Electronic Batch Record (EBR) capabilities in a regulated pharmaceutical manufacturing environment.
This role will drive the digitalization of batch processes, ensuring seamless integration between manufacturing, quality, and IT systems, while maintaining full compliance with GxP and regulatory requirements.
Key Responsibilities:
- Lead end-to-end delivery of MODA ES EBR implementation and rollout
- Coordinate across Manufacturing, Quality, IT, and Automation teams
- Ensure alignment with GxP, data integrity (ALCOA+), and validation standards
- Manage integration with systems such as MES, SAP, LIMS, and automation platforms
- Oversee URS, validation planning (CSV/CSA), testing (IQ/OQ/PQ), and release readiness
- Drive process standardization and digital transformation of batch records
- Manage vendors and system integrators delivering MODA ES solutions
- Track project scope, timelines, risks, and dependencies
- Lead steering committees and provide executive reporting
- Ensure smooth cutover, hypercare, and handover to operations