Global GLP/GCLP Auditor & Compliance Lead

Novartis; Ciudad de México; Hybrid; MXN 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

Novartis in Mexico City seeks an experienced auditor to conduct and support GLP/GCLP audits under the Novartis Quality System, ensuring compliance with regulations. You will review CAPAs, provide risk-based consultation to business units, and act as a subject matter expert for assigned areas.

The role leads audits, mentors auditors, and escalates critical findings to management while staying current with regulations and guidance to drive remediation and continuous improvement.

Qualifikationen

• Must be able to independently manage and objectively evaluate complex compliance issues.
• Experience with Health Authority inspections.
• Excellent verbal and written communication, organizational and interpersonal skills.
• Knowledge of applicable GxP regulations, guidelines, policies, and procedures.
• Good knowledge of computer systems validation and 21 CFR Part 11 requirements.

Aufgaben

• Support the strategic development of a global risk-based audit strategy and plan.
• Lead, plan, conduct, document and follow-up of GLP/GCLP audits according to Novartis Quality Module.
• Conduct assessments for BD&L integrations and non-GxP activities.
• Provide technical guidance, leadership, mentoring and training of auditors.

Kenntnisse

Independent judgment

Health Authority inspections

Communication skills

GxP regulations knowledge

32 CFR Part 11 knowledge

Leadership facilitation

AI/Copilot utilization

Jobbeschreibung

Novartis in Mexico City seeks an experienced auditor to conduct and support GLP/GCLP audits under the Novartis Quality System, ensuring compliance with regulations. You will review CAPAs, provide risk-based consultation to business units, and act as a subject matter expert for assigned areas.

The role leads audits, mentors auditors, and escalates critical findings to management while staying current with regulations and guidance to drive remediation and continuous improvement.