Program Manager – MES Transformation

Role : Program Manager – MES Transformation (Multi-Site, CSV, Pharma Digital Manufacturing)
Location : Greenville, NC onsite
 
Role Summary
We are seeking a senior, high-impact Project Manager to lead complex, multi-site MES transformation programs across a GxP-regulated pharmaceutical manufacturing network.
This role is accountable for end-to-end delivery of MES platforms (e.g., PAS-X, PharmaSuite, Opcenter) including deployment, integration, validation (CSV), and operationalization at scale.
The Project Manager operates with full ownership of scope, financials, governance, and regulatory readiness, ensuring all deliverables meet inspection-ready standards (GMP, GxP, 21 CFR Part 11, data integrity).
This is not a coordination role — it requires proven authority over large-scale, cross-functional programs involving IT, OT, Quality, and Manufacturing, often under high regulatory and operational pressure.
 
Required Qualifications (High Bar)
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)