ERP Compliance & Audit Lead — SOX/GxP Expert

F. Hoffmann-La Roche AG; Petaling Jaya; On-site; MYR 180,000 - 240,000; Full time

Job summary

Roche Malaysia is seeking a Senior IT Audit & Compliance Specialist to lead audit readiness and regulatory governance for ERP environments such as SAP S/4HANA and ECC. You will drive cross-functional collaboration across Finance, Supply Chain, and Manufacturing to defend controls and ensure compliance.

The role requires strong expertise in CSV, ALCOA++ data integrity, ITGCs, and SOX/IT security, with exposure to external audits and health authority inspections.

Qualifications

• 5–8+ years of hands-on IT Compliance, Audit Management, CSV, or Quality Assurance in ERP environments (SAP S/4HANA or ECC).
• Bachelor's degree in Computer Science, Information Technology, Information Systems, Business Administration, or related field.
• Experience hosting or defending systems during internal financial/GxP audits and external health authority inspections.
• In-depth knowledge of CSV, GAMP5, Annex 11, FDA 21 CFR Part 11, ALCOA++.
• ITGCs, SoD, SAP authorizations, ISO27001, vulnerability management, and access governance.
• Hands-on with SAP Solution Manager, ChaRM, ServiceNow, and GRC tools.

Responsibilities

• Plan, execute, and defend audit readiness frameworks across Finance, Supply Chain, Operations, Manufacturing, and Procurement ERP landscapes.
• Act as Audit Host Manager and SPOC for internal and external audits and health authority inspections.
• Coordinate SMEs and business owners to fulfill data requests and defend system controls.
• Manage CAPA lifecycle, root cause analysis, and timely remediation of audit findings and IT deviations.
• Ensure ERP systems comply with CSV, GxP Data Integrity, Annex 11, and GAMP standards.
• Maintain ITGCs across access, changes, operations, SoD, and emergency access; enforce security baselines.

Skills

Analytical thinking

Stakeholder management

Regulatory compliance

Auditing

Communication skills

Education

Bachelor's degree in Computer Science/IT/Information Systems/Business

Tools

SAP Solution Manager

Focused Build

ChaRM

ServiceNow (IRM/ITSM)

Veeva QualityDocs

GRC tools

Job description

Roche Malaysia is seeking a Senior IT Audit & Compliance Specialist to lead audit readiness and regulatory governance for ERP environments such as SAP S/4HANA and ECC. You will drive cross-functional collaboration across Finance, Supply Chain, and Manufacturing to defend controls and ensure compliance.

The role requires strong expertise in CSV, ALCOA++ data integrity, ITGCs, and SOX/IT security, with exposure to external audits and health authority inspections.