**Summary**:
Conduct and support GLP/GCLP audits, including integrations and non-GxP assessments, following the Novartis Quality System and current regulations. Ensure compliance with applicable standards and guidance documents. Review and approve corrective action plans for audit observations.
**About the Role**:
**Major accountabilities**:
- Support the strategic development of an effective general risk-based audit strategy and program; collect, collate, and incorporate input into audit strategy and plan.
- Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits of GLP/GCLP according to the requirements specified in the respective Novartis Quality Module. Assess the adequacy of responses (CAPA plans) to audit findings.
- Conduct assessments for companies and their vendors during BD&L; integration activities including non-GxP assessments, which include, but not limited to data reviews, IT system evaluations.
- Provide technical guidance, leadership, mentoring and training of other auditors on audit related activities.
- Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures accordingly.
- Identify and communicate quality and regulatory compliance issues to Quality Management and recommend remediation.
- Liaise as needed with the third-party management team.
- Proactively research local and global initiatives, trends and events that impact maintenance of compliance. Maintain current knowledge of regulations, standards and guidance documents.
**Key performance indicators**:




- Complete audits/assessments promptly and accurately.
- Ensure findings and reports meet timelines, procedures, and Key Quality Indicators (KQIs).
- Analyze audit metrics and non-compliance causes effectively.
- Escalate issues through proper channels promptly.
- Communicate and support business partners thoroughly and accurately.
**Minimum Requirements**:
**Work Experience**:
- 7+ years of GLP/GCP/Pharmaceutical Industry/Health Authority experience or equivalent.
- 5 years of GCP/PV auditing experience
**Skills**:
- Ability to independently manage and objectively evaluate complex compliance issues with mínimal supervision.
- 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 21CFR Part 11 requirements.
- Leadership and facilitation skills
- International travel expectation 25%.
**Languages**:
- English.
Division
Biomedical Research
Business Unit
Innovative Medicines
Location
Mexico
Site
INSURGENTES
Company / Legal Entity
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

📌 Global Audit and Compliance Professional (Baja California Sur)
🏢 Novartis
📍 Baja California Sur