Senior MES Program Lead — GMP/GxP, Multi-Site

Katalyst CRO; Greenville (NC); Presencial; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

Katalyst CRO is seeking a senior, high-impact Project Manager to lead complex, multi-site MES transformation programs within a GxP-regulated pharma network. You will own end-to-end delivery of MES platforms (Werum Client-X, PharmaSuite, Opcenter), including deployment, validation (CSV), and operationalization at scale.

Role requires full ownership of scope, schedule, budget, risks, and governance with strong cross-functional leadership across Manufacturing, Quality, Validation, IT, and external

Formación

• 10-15+ years of program/project management in regulated pharma/biotech environments.
• Proven leadership of at least one full-cycle MES implementation.
• Demonstrated ownership of multi-site or large-scale ($5M+) programs.
• Strong experience with CSV lifecycle and validation deliverables (VP, URS, FS/DS, IQ/OQ/PQ, RTM).
• Deep familiarity with GMP/GxP, data integrity, and regulatory inspections.
• Experience managing complex IT/OT integrations in manufacturing environments.
• Track record of financial ownership (budgeting, forecasting, variance management).
• Demonstrated authority in cross-functional leadership (Manufacturing, QA, Validation, IT, Engineering).

Responsabilidades

• Lead end-to-end MES transformation programs across multiple pharmaceutical manufacturing sites, from strategy and design through deployment, validation, go-live, and operationalization.
• Own overall program scope, schedule, budget, resources, risks, dependencies, and delivery governance for large-scale MES initiatives.
• Manage full-cycle implementation of MES platforms such as Werum Client-X, Körber PharmaSuite, Siemens Opcenter, or equivalent pharmaceutical MES solutions.
• Lead CSV/CSA activities and ensure validation deliverables including VP, URS, FS/DS, IQ/OQ/PQ, RTM, test scripts, deviations, and validation summary reports are completed on schedule.
• Ensure MES solutions comply with GMP/GxP, 21 CFR Part 11, data integrity, electronic records/signatures, and regulatory requirements.
• Direct complex IT/OT integrations between MES and systems such as ERP, LIMS, SCADA, DCS, PLC, historians, serialization, and laboratory systems.
• Provide executive-level leadership across Manufacturing, Quality, Validation, IT, Engineering, Automation, and external vendors/system integrators.

Conocimientos

Project management

Regulatory compliance

Leadership

CSV/Validation

Budgeting & forecasting

Vendor management

Educación

Bachelor's degree in a related field

Herramientas

Werum Client-X

Körber PharmaSuite

Siemens Opcenter

Descripción del empleo

Katalyst CRO is seeking a senior, high-impact Project Manager to lead complex, multi-site MES transformation programs within a GxP-regulated pharma network. You will own end-to-end delivery of MES platforms (Werum Client-X, PharmaSuite, Opcenter), including deployment, validation (CSV), and operationalization at scale.

Role requires full ownership of scope, schedule, budget, risks, and governance with strong cross-functional leadership across Manufacturing, Quality, Validation, IT, and external