Summary
Location: Remote/Mexico (or Remote/Canada for Canadian role, please see REQ-)
Novartis will not offer relocation support for this role.
Are you passionate about safeguarding quality and driving continuous improvement across a global healthcare organization? As a Global GMP Quality Auditor at Novartis, you will play a critical role in ensuring compliance, quality, and patient safety across our global network. This is an opportunity to work with diverse manufacturing sites, development centers, contract manufacturers, laboratories, warehouses and suppliers, using your expertise to identify risks, strengthen quality systems, and influence positive change. If you thrive in a collaborative environment and are motivated by making a meaningful impact on healthcare around the world, we encourage you to apply.
About The Role
Key Responsibilities
Plan, lead, and execute GMP audits across general operations and external partners.
Assess compliance with regulations, quality standards, procedures, and guidance documents.
Document audit observations, prepare reports,
and communicate findings to stakeholders.
Review and approve corrective and preventive action plans addressing audit findings.
Provide expert guidance and training on audit activities .
Escalate critical compliance issues and support timely mitigation activities when required .
Maintain expertise in evolving regulations, industry standards, and quality expectations.
Essential Requirements
Degree in Chemistry, Pharmacy, Biology, Engineering, or another related scientific discipline; other degrees with relevant experience may be considered .
Minimum 10 years of broad experience in the pharmaceutical or medical device industry, including QA/QC management and manufacturing, development, or other relevant experience such as working at a regulatory health authority .
Expertise in at least one of the following areas: drug product (DP) manufacturing, biologics, sterile manufacturing, laboratories, microbiology
📌 Global Gmp Quality Auditor (Xico)
🏢 CDMS
📍 Xico