Fresenius Medical Care

SAP Center of Excellence (COE) Compliance SME

Bengaluru, KA Full time

The SAP S/4HANA Compliance SME is responsible for validating that SAP system changes, fixes, and enhancements comply with internal controls, audit requirements, and regulatory standards (e.g., GXP, SOX, IFRS, local statutory rules). This role ensures that business and IT controls embedded in SAP processes continue to operate effectively after every change, thereby protecting the organization from financial, operational, and compliance risks in a sustain (run) environment.

Goal of function:

The SAP COE will primarily enable transiting FME from third-party and build in-house expertise in GBS across core business process ( RTR, QTC,S2P,PTM,SC,..etc) ; SAPS/4HANA application support (L2/L3) and Incident, problem ,and change management

Tasks*

Compliance & Control Testing

  • Develop Master validation plans to ensure that, at the end of the project, the system meets FDA compliance requirements require 21 CFR Part 11 and Part 820 validation.
  • Develop SDLC Validation Deliverables for the project-Qualification Protocol, User Requirement Specifications (URS), System Requirements Specification, Risk Assessment, Test Scripts, Validation Reports and System release report.
  • Evaluate the system(s) changes using Risk based approach and assigning appropriate level of validation requirements to ensure the compliance is established and maintained throughout the computer system life cycle.
  • Address deviations associated with computer system validation for business / GxP impact and resolution by recommending the corrective measures with all objectives of meeting validation requirements.
  • Author computerized system validation SOPs and policies as required
  • Design and execute compliance test scenarios aligned to financial, operational, and IT controls in SAP S/4HANA.
  • Validate segregation of duties (SoD), authorization concepts, and access controls after system changes.
  • Test key controls for core business processes (P2P, O2C, R2R, A2R, etc.).
  • Ensure regulatory and statutory changes are tested and implemented correctly.

Change & Release Assurance

  • Perform compliance testing for incidents, problem fixes, enhancements, and periodic releases.
  • Assess risk of changes and define scope of compliance testing accordingly.
  • Participate in release readiness and change approval forums (CAB).

Audit & Risk Support

  • Support internal and external audits by providing test evidence and documentation.
  • Validate remediation of audit findings and control gaps.
  • Work closely with Internal Audit, Finance Controls, and GRC teams.

Documentation & Evidence Management

  • Maintain test scripts, compliance scenarios, and control matrices.
  • Prepare audit-ready documentation: test results, screenshots, sign-offs, and control evidence.
  • Ensure traceability between business requirements, controls, and test results.

Tools & Automation

  • Execute and maintain compliance test cases using SAP Solution Manager, GRC, or testing tools.
  • Identify opportunities for automating compliance testing and control validations.

2) Stakeholder Engagement

  • Global Business Services Leadership
  • Global ITS Organization
  • SAP System Integrator(s) / SAP COE Lead, Service Manager,
  • Business Process Owners & Operations Leaders
  • Finance, HR, Procurement, Supply Chain Leadership
  • External SAP and Technology Partners

3) Miscellaneous tasks:

Tasks not performed regularly which are nevertheless a distinct part of the job, or special tasks / project work.

Qualifications, experience.

1) Required training and education:

  •   Bachelor’s degree in IT, Finance, Accounting, or Business Systems.
  •   4–10 years of experience in SAP testing, compliance testing, or controls validation.
  •   Strong experience in SAP S/4HANA or ECC financial and operational processes.
  •   Experience working in ITIL-based sustain or AMS environments.

2) Required professional experience (in years):

  • Hands-on experience with SAP S/4HANA AMS ,AD/ SI support.
  • Strong understanding of SAP modules such as: FI/CO,MM,SD,PP,EWM and WM
  • Experience supporting production environments.
  • Experience in defect tracking tools (e.g., Jira, ServiceNow, HP ALM).
  • Experience with automation tools (e.g., SAP CBTA, Tricentis Tosca).
  • Experience in global rollouts or multi-country implementations.

3) Important personal qualities:

  • Works closely with SAP Functional Consultants, Security/GRC teams, and Release Management.
  • Supports continuous releases and regulatory change cycles.
  • Contributes to SAP COE governance, quality, and risk frameworks.
  • Drives standardization of compliance testing practices across regions.

4) Other specialized knowledge:

c) IT skills

Compliance & Controls

  • Expertise in developing and implementing robust validation frameworks, managing risks and ensuring regulatory compliance for computerized systems.
  • Involved in designing, coordinating training and mentorship programs on IT CSV topics and driving continuous improvement projects and ensure successful audits and inspections.
  • Proved track record in thriving to learn and adopt new practices around software validation approach in a fast paced, competitive, and challenging environment with experience in CSV compliance and Quality IT compliance.
  • Involved and responsible in completing end to end validation of world leading innovative Robotics project, including the Data Flow, Data Content validation from various clients to AWS Cloud system.
  • Extensive experience with 21 CFR Part 11 (Electronic Records, Electronic Signatures, Audit Trails and Security events), 21 CFR part 210 /211, Health Canada Guidelines (GUI-0029), EU - Annexure 11.
  • Expertise with Quality Management System- Development, Validation, Training, launch, and adoption of Centralized Quality Systems. Expertise in Corrective Action and Preventive Action (CAPA) investigation to identify and evaluate the problem or non-conformance
  • Strong knowledge of GXP, CSV, CSA, SOX controls and ITGCs in SAP.
  • Experience with SAP GRC Access Control and Risk Management.
  • Understanding of authorization concepts, role design, and SoD rulesets.
  • Familiarity with audit frameworks (SOX, COSO, COBIT).

Testing Tools

  • Experience with SAP Solution Manager Test Suite, Jira, ALM, or similar.
  • Exposure to test automation tools (e.g., Tosca, Worksoft) is a plus.

d) Product knowledge

SAP & Process Knowledge

  • Strong understanding of SAP business processes:
  • Procure-to-Pay (P2P)
  • Order-to-Cash (O2C)
  • Record-to-Report (R2R)
  • Asset Accounting (A2R)
  • Knowledge of SAP S/4HANA Fiori and reporting.
  • SAP Products
  • SAP S/4HANA
  • SAP BW/4HANA / SAC
  • SAP Solution Manager / Focused Run
  • SAP Fiori & UI5
  • SAP CPI / PI-PO
  • Supporting Platforms
  • ITSM tools (ServiceNow preferred)
  • Monitoring tools (SAP ALM, APM, AIOps)
  • Cloud platforms (AWS / Azure / GCP – SAP workloads)

5 ) Special personal requirements:

Please list requirements such as willingness to travel or work weekends or shifts etc.

  •   High attention to detail and control-oriented mindset.
  •   Strong documentation and evidence management discipline.
  •   Ability to communicate with Finance, Audit, and IT stakeholders.
  •   Strong analytical and risk assessment skills.
  •   Ability to work independently in a high-accountability environment.