Description
The Computer Systems Validation Expert will lead validation and testing for the Moderna ERP platform, including S/4, BTP, and MDG. The role coordinates cross-functional stakeholders, develops risk-based validation strategies, manages change control and requirements traceability, oversees testing and validation evidence, and ensures compliance with GxP and GMP requirements. Candidates need at least 10 years of relevant experience in a regulated environment, 10 years of CSV experience with SAP systems, regulatory and CSV/SDLC expertise, and experience validating AI solutions in a GMP environment.
