Global Gmp Quality Auditor

CDMS; Xico; Remote; MXN 1,681,000 - 2,428,000; Full time

Job summary

Novartis is seeking a Global GMP Quality Auditor to safeguard quality and patient safety across a global network. You will audit manufacturers, labs, and suppliers, identify risks, and drive improvement in quality systems.

This role is remote with extensive travel and requires strong regulatory knowledge and English communication. The candidate will have 10+ years in pharma/medical device QA/QC, experience with regulatory authorities, and expertise in at least one manufacturing or quality area.

Qualifications

• Degree in Chemistry, Pharmacy, Biology, Engineering or related discipline.
• Minimum 10 years in pharma/medical device QA/QC/manufacturing or regulatory health authority experience.
• Expertise in DP manufacturing, biologics, sterile manufacturing, labs, microbiology, packaging, APIs, excipients, medical devices, CV, or quality systems.
• Strong knowledge of regulatory requirements and interaction with Health Authorities.
• Excellent interpersonal skills and stakeholder management.
• Willingness to travel around 60% globally.
• Advanced oral and written English.

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 activities when required.
• Maintain expertise in evolving regulations, industry standards, and quality expectations.

Skills

Regulatory knowledge

Auditing

Stakeholder management

English communication

Global travel

Education

Degree in Chemistry/Pharmacy/Biology/Engineering

Job description

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 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 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, packaging, active pharmaceutical ingredients (API), excipients, medical devices, computer system validation, or quality systems .
• Excellent knowledge of regulatory requirements, with experience and/or interaction with local Health Authorities and sporadically with other Health Authorities; sound and practical judgement in the interpretation and application of regulations and standards .
• Strong interpersonal skills, including diplomacy, persuasion, and stakeholder management.
• Willingness to travel approximately 60% globally .
• Advanced oral and written English communication skills.

Desirable Requirements

• 3 years auditing experience
• Proficiency in an additional language such as German, French, Italian, Chinese, or Spanish.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and accommodation

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to ****** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Benefits And Rewards

Learn about all the ways we'll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)