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 Stories
* Functional Design
* Configuration
* Custom Development
* Review and approve:
* Functional Specifications
* Technical Design Documents
* Partner 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 Planning
* IQ/OQ/PQ execution oversight
* Define 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 compliance
* Change Management controls
* Segregation of Duties (SoD) design
* Align 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 workflows
* SoD rulesets
* Ensure integration between GRC and Identity Access Management platforms.
Data Integrity & Master Data Governance
* Ensure compliance with ALCOA++ principles across:
* Master Data Management
* Transactional Data
* Reporting & Analytics
* Test Data Management
* Data Migration validation
* Data Object classification
* Audit trail review determination and activation
* Archiving and retention policies
Audit & Inspection Readiness
* Lead SAP compliance inspection readiness activities:
* Internal audits
* Mock regulatory inspections
* Prepare inspection readiness documentation and evidence packages.
* Act as primary SAP compliance SME during regulatory inspections.
Stakeholder Management
* Serve as compliance interface between:
* Quality & Regulatory Affairs
* Cybersecurity
* Finance Controls
* System Integrators
* External Auditors
* Provide executive-level reporting on compliance risk posture and readiness metrics
* SAP Compliance Strategy & Roadmap
* Integrated GxP / SOx / GRC Governance Model
* Validation Strategy (VS) & SDLC Deliverables
* GRC Role & Access Framework
* Go-Live Compliance Readiness Assessment
Required Qualifications & Experience
* 10+ years’ experience in enterprise system compliance leadership
* Proven delivery of SAP S/4HANA GxP validated implementations
* Deep expertise in:
* QMS Implementation aligned with GAMP 5 & ICH Q8
* FDA 21 CFR Part 11 / EU Annex 11
* SOx ITGC frameworks
* Experience 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 Control
* Data migration governance tools (LTMC, LSMW, Migration Cockpit)
* Validation lifecycle tooling (Cloud ALM, Kneat Gx, Veeva Vault QMS, equivalent)
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