Job Description
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. LI-Hybrid Location: Insurgentes, Mexico City
Support the strategic development of an effective integral 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. Proactively research local and global initiatives, trends and events that impact maintenance of compliance. 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. 3+ years of GxP auditing experience. GCP/PV/GLP auditing experience preferred.
Skills:
Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision. Languages: English. Additional languages including German and French considered a plus
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