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.
You will:
- 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., Onapsis code profiling, kernel patching), and system access controls across ERP platforms.
- Provide technical and quality oversight for key strategic managed service providers, reviewing vendor SOC 1 / SOC 2 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, ISO 27001, 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.
Call to Action
Ready to bring your unique qualities to Roche and make an impact? Apply now and join us in our mission to shape the future of healthcare.
#RDT2026
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.
