Global GMP Quality Auditor — Remote Impact & Compliance

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

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.