SAP Validation Compliance Expert

Job Summary

A company is looking for a SAP Principal IT Validation and Compliance.

Key Responsibilities

• Provide global oversight for SAP system validation across all SAP modules and support integrations
• Lead validation direction and approval of SAP lifecycle deliverables including URS, FRS/FS, and Risk Assessments
• Manage and provide oversight of managed validation services for SAP implementation, upgrade, and enhancement projects

Required Qualifications

• 15+ years of experience in a cGMP environment in computer system validation
• Direct SAP validation experience in an FDA-regulated manufacturing or CDMO environment
• Strong working knowledge of SAP lifecycle validation
• Expert understanding of 21 CFR Part 11, EU Annex 11, and regulatory guidance on Data Integrity
• Experience with SAP-specific compliance controls and SAP security & role design