Global GLP/GCLP Audit Lead | Compliance & Risk

Novartis AG; Guamúchil; Hybrid; MXN 700,000 - 950,000; Full time

Job summary

Novartis in Mexico City is seeking an experienced Quality Audit professional to lead global GLP/GCLP audits and advise on risk-based regulatory compliance programs.

You will provide technical guidance, mentor other auditors and ensure CAPA plans are robust and timely, while aligning with the company's strategic quality initiatives. Travel up to 25% is expected as part of BD&L integrations and audits.

Qualifications

• 7+ years of GLP/GCP/Pharmaceutical Industry/Health Authority experience or equivalent.
• 3+ years of GxP auditing experience. GCP/PV/GLP auditing experience preferred.
• International travel expectation 25%
• undefined

Responsibilities

• Lead, plan, conduct, document and follow-up of GLP/GCLP audits per Novartis Quality Module.
• Assess adequacy of CAPA responses to audit findings.
• Conduct assessments for BD&L integrations including non-GxP assessments.
• Provide guidance, mentoring and training to other auditors.
• Escalate critical findings to management and support immediate actions.
• Identify and communicate quality issues and recommend remediation.

Skills

Independent compliance management

HA inspections

Leadership and facilitation

GxP regulations knowledge

21 CFR Part 11 knowledge

Communication skills

AI Copilot awareness

Tools

Computer systems validation

AI copilots

Job description

Novartis in Mexico City is seeking an experienced Quality Audit professional to lead global GLP/GCLP audits and advise on risk-based regulatory compliance programs.

You will provide technical guidance, mentor other auditors and ensure CAPA plans are robust and timely, while aligning with the company's strategic quality initiatives. Travel up to 25% is expected as part of BD&L integrations and audits.