Global GLP/GCLP Auditor & QA Advisor (Hybrid)

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.; Ciudad de México; Hybrid; MXN 900,000 - 1,300,000; Full time

Job summary

Novartis Farmacéutica S.A. de C.V. is seeking an experienced GLP/GCLP auditor to lead global quality regulatory compliance audits and to provide expert guidance across business units in Mexico City.

The role requires strong risk assessment, regulatory knowledge, and the ability to mentor other auditors. Responsibilities include developing an effective audit strategy, evaluating CAPA responses, and communicating findings to management.

Qualifications

• 7+ years of GLP/GCP/pharma/Health Authority experience
• 3+ years of GxP auditing experience
• English required; additional languages (German, French) a plus

Responsibilities

• Lead and conduct global quality regulatory compliance audits (GLP/GCLP) according to the Novartis Quality Module.
• Review CAPA plans and ensure timely follow-up and closure.
• Provide guidance, leadership, mentoring, and training of other auditors.
• Escalate critical findings to management and support immediate follow-up actions.

Skills

GLP/GCP auditing

Regulatory compliance

Quality systems

Risk assessment

Leadership

Communication

Training

CAPA management

Tools

Copilot

Job description

Novartis Farmacéutica S.A. de C.V. is seeking an experienced GLP/GCLP auditor to lead global quality regulatory compliance audits and to provide expert guidance across business units in Mexico City.

The role requires strong risk assessment, regulatory knowledge, and the ability to mentor other auditors. Responsibilities include developing an effective audit strategy, evaluating CAPA responses, and communicating findings to management.