Compliance Lead (SAP S/4HANA)

Simarn Solutions
  • Pennsylvania
    30+ days ago

    Job Description

    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.

    Numbers & Facts

    LocationPennsylvania

    Skills

    • Biotech and Pharmaceuticalunmatched
    • Change Requests/Ordersunmatched
    • Communication Skillsunmatched
    • Computer Systemsunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Data Migrationunmatched
    • Data Qualityunmatched
    • Documentationunmatched
    • Embedded Systemsunmatched
    • Functional Testingunmatched
    • GxPunmatched
    • Information Technology & Information Systemsunmatched
    • Leadershipunmatched
    • Maintain Complianceunmatched
    • Migration Strategyunmatched
    • Problem Solving Skillsunmatched
    • Regression Testingunmatched
    • Regulationsunmatched
    • Riskunmatched
    • Root Cause Analysisunmatched
    • SAPunmatched
    • Software Development Lifecycle (SDLC)unmatched
    • Software Testingunmatched
    • Systems Analysisunmatched
    • Team Lead/Managerunmatched
    • Technical Leadershipunmatched
    • Test Strategyunmatched
    • Time Managementunmatched
    • Validation Documentationunmatched

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