Audit Manager - RDT Quality, Risk & Compliance

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
The IT Audit & Inspection Readiness Senior Specialist serves as the primary day-to-day partner, shield, and facilitator for IT/RDT teams and business when navigating internal audits, external certifications, and regulatory inspections.
This is not a traditional auditor role focused on testing and issuing findings. Instead, it is an enablement and orchestration role. Your objective is to stand shoulder-to-shoulder with technical colleagues, take the operational friction out of audit processes, translate technical implementations into audit-ready evidence, and drive pragmatic issue remediation.
Embedded directly within our Governance, Risk, and Compliance (GRC) framework, you will help build an agile evidence repository, build sustainable audit & inspection readiness, and gradually introduce internal control self-assessments (iCSAs) as the capability matures.

Your Responsibilities
Audit Lifecycle & Inspection Facilitation (End-to-End Orchestration)
Single Point of Contact (SPOC): Act as the liaison and cross-coordination between IT/RDT teams and incoming audit or inspection teams.
Intake Management: Triage incoming requests /lists, clarify ambiguous requests with auditors, and eliminate duplicate or out-of-scope demands for proper planning.
Evidence Quality Check: Review and validate requests before submission, verifying they directly answer the auditor's request while safeguarding sensitive data.
IT/RDT Compliance Enablement & Sustainable Remediation
Audit Artifacts. Standardize request channels, analyze repeated evidence, and manage the audit calendar to prevent operational disruptions and support the teams proactively. 
CAPA Partnership: Collaborate with RDT Subject Matters and Practice Owners to perform root-cause analysis (RCA) on audit findings to boost an improvement and quality mindset.
Remediation Tracking & Evidence Closure: Continuously track remediation milestones and coordinate final sign-off with auditors.

GRC Framework Integration & Readiness Evolution
GRC Maintenance: Keep the central GRC tool updated with active audit engagements, artifact repositories, control mappings, and open finding statuses.
Continuous Readiness & Metrics: Build and maintain reusable, standardized evidence packages for recurring controls and trending analysis (workload distribution, finding aging, etc.).
Self-Assessments & Proactive Checks (Growth Scope): As the reactive audit cycle stabilizes, partner with teams to run informal, lightweight Control Self-Assessments (iCSAs) against for example baseline frameworks to proactively detect gaps and support improvement actions.

Who You Are
Experience: At least 5  years of practical experience in IT Audit, IT Compliance, GRC coordination, or an IT Service/Operations role with substantial audit exposure.
Education: Degree in Computer Science, Information Systems, Engineering, Business Informatics, or equivalent practical tech background.
Technical Background: Working familiarity with IT infrastructure, cloud architectures, identity & Access Management (IAM), backup/resilience and Change Management - are a plus.
GRC (Governance, Risk and Compliance)  Understanding: Understanding of how control frameworks (e.g., ISO 27001, NIS2, SOX ITGC) map into practical IT workflows - are a plus.
Regulatory experience: Proven experience in aligning organizational processes with global regulatory frameworks, including ISO standards (e.g. 9001, 13485, 27001), GxP guidelines, FDA mandates (e.g. 21 CFR Part 11, Annex 11), SOX IT General Controls, and data privacy laws (e.g. GDPR, CCPA).
Languages: English Fluent. Must be completely comfortable writing, presenting to international teams, and communicating across distributed teams in English.
Valued Certifications: Certified Information Systems Auditor (CISA), Certified in Risk and Information Systems Control (CRISC), ISO/IEC 27001 Lead Implementer / Auditor, ITIL Foundation credentials - are a plus.
 
 

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.