Senior IT Audit & Compliance Specialist (ERP Systems Management)

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

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position Senior IT Audit & Compliance Specialist (ERP Systems Management) The Senior IT Audit & Compliance Specialist (ERP Systems Management) serves as a strategic and technical expert responsible for embedding end-to-end audit readiness, quality oversight, and regulatory controls across enterprise-wide ERP systems (e.g., SAP S/4HANA ASPIRE, SAP ECC, EWM, and connected value stream platforms).

The role bridges complex regulatory mandates across GxP (CSV, Annex 11, 21 CFR Part 11), ICFR (SOX, ITGCs), and IT Security, ensuring continuous compliance, proactive risk mitigation, and seamless execution during internal/external audits and health authority inspections. Operating within RDT ERP Systems Management – Compliance, this position plays a critical part in protecting system integrity and operational excellence across Roche's enterprise digital ecosystem.

The Opportunity

In this role, you will lead audit readiness, technical compliance, and regulatory governance across multi-value stream ERP environments.

• Plan, execute, and defend audit readiness frameworks across Finance, Supply Chain, Operations, Manufacturing, and Procurement ERP landscapes.
• Act as the primary Audit Host Manager and Single Point of Contact (SPOC) for internal Group Audits (GARA), external statutory audits (e.g., KPMG for ICFR/SOX), and Health Authority GxP inspections.
• Coordinate cross-functional Subject Matter Experts (SMEs), System Owners, and Business Process Owners (BPOs) to fulfill audit data requests, conduct technical walkthroughs, and defend system controls.
• Manage the end-to-end Corrective and Preventive Action (CAPA) lifecycle, driving root cause analysis (RCA) and ensuring on-time remediation of audit findings and IT deviations.
• Ensure all regulated ERP systems comply with Roche Computerized System Validation (CSV) policies, GxP Data Integrity (ALCOA++), Annex 11, 21 CFR Part 11, GAMP standards, and AI validation SOPs.
• Maintain and monitor IT General Controls (ITGCs) across User Access & Authorizations, Change Management (SolMan/ChaRM), IT Operations, Segregation of Duties (SoD), and emergency firefighter access.
• Enforce Minimum Security Baseline standards, vulnerability management (e.g., Onapsiscode profiling, kernel patching), and system access controls across ERP platforms.
• Provide technical and quality oversight for key strategic managed service providers, reviewing vendor SOC1 / SOC2 reports, vendor quality assessments (VQA), and third‑party risk profiles.

Who you are

We are looking for a highly analytical, compliance‑minded expert who excels at translating regulatory requirements into robust operational controls. To succeed in this role, you bring:

• Experience: Minimum 5–8+ years of hands‑on experience in IT Compliance, Audit Management, CSV, or Quality Assurance within enterprise ERP environments (preferably SAP S/4HANA or ECC) in pharmaceutical, life sciences, or highly regulated industries.
• Education: A University Bachelor’s degree in Computer Science, Information Technology, Information Systems, Business Administration, or a related technical/regulatory field.
• Audit & Inspection Track Record: Proven background hosting or defending systems during internal financial/GxP audits and external health authority inspections within global, matrixed environments.
• GxP & CSV Expertise: In‑depth knowledge of Computerized System Validation (CSV), GAMP5, EudraLex Annex 11, FDA 21 CFR Part 11, and GxP Data Integrity (ALCOA++) principles.
• ICFR, SOX & Security Knowledge: Solid understanding of IT General Controls (ITGCs), Segregation of Duties (SoD), SAP Authorizations, ISO27001, vulnerability management, and access governance.
• Tool & Platform Proficiency: Hands‑on experience with SAP Solution Manager (SolMan), Focused Build, ChaRM, ServiceNow (IRM/ITSM), Veeva QualityDocs, and GRC tools.
• Communication & Leadership: Strategic problem‑solving mindset with exceptional stakeholder management, negotiation, and communication skills to collaborate effectively with executive leadership, legal counsel, and external auditors.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life‑changing healthcare solutions that make a global impact. Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.