Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
TheIT Audit& Inspection Readiness Senior Specialistserves 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 general 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.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
📌 Audit Manager - RDT Quality, Risk & Compliance (Madrid)
🏢 Roche
📍 Madrid