Overview 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.
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.
Responsibilities 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
Qualifications 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
Roche is an Equal Opportunity Employer.
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