Global GMP Quality Auditor

About the role

Novartis is hiring a Global GMP Quality Auditor (Band Level 4) to safeguard quality and drive continuous improvement across its global healthcare organization. The role works with manufacturing sites, development centers, contract manufacturers, laboratories, warehouses and suppliers to identify risks and strengthen quality systems. It is a remote position based in Mexico (a Canadian version exists under a separate requisition number); relocation support is not offered.

Key responsibilities

• Plan, lead and execute GMP audits across global 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 when required
• Maintain expertise in evolving regulations, industry standards and quality expectations

Required profile

• Degree in Chemistry, Pharmacy, Biology, Engineering or another related scientific discipline; other degrees with relevant experience may be considered
• At least 10 years of broad experience in the pharmaceutical or medical device industry, including QA/QC management and manufacturing, development or work at a regulatory health authority
• Expertise in at least one area: drug product manufacturing, biologics, sterile manufacturing, laboratories, microbiology, packaging, API, excipients, medical devices, computer system validation or quality systems
• Excellent knowledge of regulatory requirements and experience interacting with local health authorities
• Willingness to travel approximately 60% globally
• Advanced oral and written English

Desirable

• 3 years of auditing experience
• Proficiency in another language such as German, French, Italian, Chinese or Spanish

Desired skills: collaboration, data integrity, decision making, leadership and risk management.