Job Title : SAP S / 4 Hana Compliance Lead Consultant
Reporting To : Program Sponsor / Quality & Technology Lead (Client-Side)
Engagement Type : Contract / Fixed-Term Consultancy
Location : Hybrid (Global Program)
Duration : Program Lifecycle (Source Implement Deploy Hypercare)
Role Purpose
The Compliance Lead Consultant will be accountable for implementing the end-to-end compliance strategy for the design, implementation, and maintenance of GxP, SOx, and SAP GRC Controls within SAP S / 4HANA and our global transformation program.
The role ensures regulatory compliance is embedded by design across solution architecture, business process design, system configuration, data governance, and operational controls — enabling audit-ready deployment aligned with FDA, EMA, MHRA, ICH, GAMP 5 and corporate governance expectations.
This role represents the Quality & Technology Lead as the senior compliance authority within the SAP program and serves as the primary interface between the program and Quality, Digital & Technology (DT), Cyber Security, Internal Audit and Finance Controls.
Key Responsibilities
SAP Program-Level Compliance Leadership Representation
- Ensure the Compliance Framework Charter is integrated into the SAP Program covering :
- Validation of GxP Computer System (includes SAP, Industry 4.0 & 5.0 etc)
- SOx & IT General Controls (IT GC)
- SAP Governance Risk & Compliance Access & Process Controls
- Manage and provide progress reports on the delivery of the Compliance Framework with our preferred Third Party Integrator and Validation Partner (Selection in Progress) :
- Align with the Charter that is shared with our Validation Partner
- ISPE guidance
- FDA 21 CFR Part 11 / Annex 11
- SOx 404 controls
- Act as the escalation point for compliance risk decisions across the program
SAP S / 4HANA Design & Build Oversight
Ensure compliance Framework principles are embedded during :Business Blueprint & User StoriesFunctional DesignConfigurationCustom DevelopmentReview and approve :Functional SpecificationsTechnical Design DocumentsPartner with system integrators to enforce compliant design patterns and documentation standards.Validation & GxP Compliance
Lead the CSV strategy for SAP S / 4HANA and integrated landscape :System Categorisation (GAMP 5)Validation PlanningIQ / OQ / PQ execution oversightDefine validation deliverables and acceptance criteria.Ensure validation traceability from :Oversee vendor validation packages and ensure regulatory alignment.Partner with Finance, Internal Audit, and Controls teams to ensure :SOx ITGC complianceChange Management controlsSegregation of Duties (SoD) designAlign SAP configuration and processes with SOx audit expectations.Own the design and rollout of SAP GRC capabilities including :Access Control (AC)Process Control (PC)Define :Emergency access procedures (Firefighter)User provisioning workflowsSoD rulesetsEnsure integration between GRC and Identity Access Management platforms.Data Integrity & Master Data Governance
Ensure compliance with ALCOA++ principles across :Master Data ManagementTransactional DataReporting & AnalyticsTest Data ManagementData Migration validationData Object classificationAudit trail review determination and activationArchiving and retention policiesAudit & Inspection Readiness
Lead SAP compliance inspection readiness activities :Internal auditsMock regulatory inspectionsPrepare inspection readiness documentation and evidence packages.Act as primary SAP compliance SME during regulatory inspections.Stakeholder Management
Serve as compliance interface between :Quality & Regulatory AffairsCybersecurityFinance ControlsSystem IntegratorsExternal AuditorsProvide executive-level reporting on compliance risk posture and readiness metricsSAP Compliance Strategy & RoadmapIntegrated GxP / SOx / GRC Governance ModelValidation Strategy (VS) & SDLC DeliverablesGRC Role & Access FrameworkGo-Live Compliance Readiness AssessmentRequired Qualifications & Experience
10+ years’ experience in enterprise system compliance leadershipProven delivery of SAP S / 4HANA GxP validated implementationsDeep expertise in :QMS Implementation aligned with GAMP 5 & ICH Q8FDA 21 CFR Part 11 / EU Annex 11SOx ITGC frameworksExperience working with Tier 1 system integrators (Accenture, Deloitte, Capgemini, IBM, etc.)Strong understanding of regulated manufacturing and supply chain processes.Technical Skills
SAP Solution Manager / Focused Build (testing & documentation management)SAP GRC Access Control and Process ControlData migration governance tools (LTMC, LSMW, Migration Cockpit)Validation lifecycle tooling (Cloud ALM, Kneat Gx, Veeva Vault QMS, equivalent)#J-18808-Ljbffr