Support the development and maintenance of the overall GxP and validation strategy for the SAP S/4HANA program
Coordinate validation planning activities across workstreams, releases, and deployment phases
Ensure alignment with applicable GxP regulations, internal quality standards, CSV/CSA methodologies, and data integrity principles
Advise program leadership on compliance impacts, validation expectations, and regulatory considerations related to system implementation activities
Support definition of validation deliverables, governance processes, and documentation requirements
Review and provide guidance on validation-related plans, deliverable structures, and compliance approaches prepared by implementation teams
Facilitate collaboration between Quality Assurance, IT, business stakeholders, and system integrator teams
Support risk assessment planning and traceability strategy discussions for GxP-relevant processes and systems
Participate in governance forums, quality reviews, and project planning sessions to ensure compliance activities are appropriately integrated into the program timeline
Monitor validation readiness and identify potential compliance gaps, risks, or dependencies requiring escalation
Support audit and inspection readiness activities related to the program
Provide oversight and coordination for validation scheduling, dependencies, and milestone tracking

7+ years of experience in GxP-regulated environments
Strong experience supporting validation and compliance activities for large enterprise system implementations
Experience with SAP ERP or SAP S/4HANA transformation programs
Solid understanding of GAMP 5, CSV/CSA methodologies, FDA 21 CFR Part 11, EU Annex 11, data integrity principles, and risk-based validation approaches
Experience coordinating cross-functional stakeholders in complex program environments
Familiarity with validation lifecycle documentation and governance processes

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GxP Compliance & Validation Planning Consultant

Key skills