Compliance Lead (SAP S/4HANA)

Senior Technical Lead / Compliance Lead (SAP S/4HANA)

Location: West Point, Pennsylvania | C2C | Hybrid (3 days onsite, 2 days remote)

Pay Rate: $75/hr

Industry: SAP S/4HANA / GxP Compliance / Pharmaceutical IT

End Date: 26-Nov-2026

Job Description
We are seeking a Senior Technical Lead / Compliance Lead with strong expertise in SAP S/4HANA and GxP-regulated environments. The ideal candidate will be responsible for providing compliance oversight, ensuring regulatory alignment, and guiding quality practices across SAP programs. This role requires hands-on experience with S/4HANA or ECC GxP functionality, validation strategies, data migration oversight, and SDLC governance using CSA principles. The position will collaborate closely with cross-functional teams, lead quality reviews, drive CAPA activities, and ensure audit readiness across systems and processes.

Responsibilities

• Provide end-to-end quality oversight for GxP computerized systems, including audit preparation and remediation.
• Lead and validate SAP S/4HANA/ECC GxP functionality, including data migration, interface qualification, and report validation.
• Define and implement risk-based validation strategies using Computer System Assurance (CSA) frameworks.
• Drive functional and regression testing strategy, ensuring quality requirements are embedded from project inception.
• Conduct root cause analysis for IT system incidents, develop CAPAs, and ensure timely closure and verification.
• Serve as SME for Data Integrity, overseeing remediation efforts and ensuring compliance controls.
• Review and approve SDLC deliverables, system change requests, and validation documentation.
• Guide teams in authoring SOPs, WIs, and compliant documentation practices.
• Lead cross-functional meetings to resolve compliance issues and provide governance for system quality.
• Collaborate with stakeholders to ensure system compliance aligns with business and regulatory expectations.

Required Qualifications

• Strong experience as a Compliance Lead in SAP S/4HANA or ECC GxP environments.
• Deep understanding of GxP, CSV/CSA, SDLC, and regulatory expectations for pharma/biotech systems.
• Experience with data migration validation, interface qualification, test planning, and risk-based approaches.
• Strong knowledge of Data Integrity principles and regulatory guidelines.
• Ability to lead CAPA, audits, investigations, and documentation governance.
• Excellent communication, leadership, and stakeholder management skills.