GxP Compliance & Validation Planning Consultant

Key Responsibilities

• 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

Required Experience

• 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

Preferred Experience

• Experience in pharmaceutical, biotechnology, or medical device industries
• Experience working within global transformation programs…