ISMS/QMS Auditor & Audit Management tool Specialist

The Position

Global Quality and Regulatory (Q&R) Compliance focuses on prevention instead of remediation. We are a role model for the right level of compliance based on a sound risk balance.

We are looking for an ISMS/QMS Auditor & Audit Management tool Specialist in Audit and Inspection Readiness, where we trustfully partner with our stakeholders, adding value from audits and ensure inspection readiness through knowledge sharing and coaching, to build a self-reliant compliant organization.

The Opportunity

In this hybrid role, you are responsible for leading and executing internal and supplier audits, contributing to our audit strategy. In parallel you are driving the rollout of our Veeva audit management tool. This includes overseeing the project, ensuring that people are trained, providing first-level support, and acting as the primary interface with the IT team together with our Technical Lead.

• Perform internal and supplier audits of the ISMS, QMS, and associated processes
• Prepare for and execute audits, write detailed reports, and communicate findings to stakeholders
• Contribute to the continuous improvement and application lifecycle management of our audit management tool
• Support the Audit Chapter in building knowledge and experience in ISMS auditing, particularly for digital products based on the ISO 27xxx family of standards
• Collaborate with the Technical Lead Audit, Q&R Compliance Network Leads, and Integrated Informatics
• Establish strong collaborative relationships across sites and global organizations to achieve key results

Who You Are

This role is for an innovative professional who brings ISMS audit experience, ideally paired with experience in IT project management, with proficiency in English, German is highly desired.

• Hold a Bachelor of Science degree in Information Technology, Sciences, Healthcare, engineering, or a technical discipline
• Experienced in leading ISMS audits based on the ISO 27xxx family of standards, including associated certifications
• Experience with the EU AI Act and with ISO 13485 based audits are a plus
• A high-level of social competence with the ability to work without supervision and make decisions
• Committed to cross-functional collaboration and able to navigate a changing organization while maintaining objectivity and respect

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!

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.

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