.Good Clinical Practices and Pharmacovigilance Sr. AuditorJob ID REQ-10025384Location: MexicoSummaryLead, support and report independent GCP/PV audits according to the NVS Quality System and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations.Ensure alignment with the strategic direction of the company and assist in driving implementation of the applicable actions. Provide consultation to NVS business units through risk-based assessments. Act as SME for assigned areas of responsibility.About the RoleMajor accountabilities:Support the strategic development of an effective global risk-based audit strategy and programme; collect, collate and incorporate input into audit strategy and plan.Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents. Perform activities with a high degree of independence.Provide technical guidance, leadership, mentoring and training of other auditors on audit related activities.Prepare audit reports according to NVS requirements and timelines.Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures.Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).Identify and communicate quality and regulatory compliance issues to Quality Management through appropriate channels as well as recommend remediation.Lead compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement as requested.Support Mock Pre-Approval Inspections (PAIs) and Health Authority (HA) inspections as needed.Review and advise on relevant global NVS policies and procedures.Proactively research local and global initiatives, trends and events that impact maintenance of compliance.Mentor junior GCP/PV staff as required.Complete any other requests from Global GxP Audit.Maintain current knowledge of regulations, standards, and guidance documents.Review and approve audit reports as required.Participate in the Lead Auditor program as requested.Key performance indicators:Execution of the risk-based Unified Quality Audit Plan (UQAP).Assigned audits led appropriately, delivered on time and according to Global GxP Audit quality standards.Accuracy of findings and completion of audits and finalization of audit reports within established timelines, procedures and agreed upon standards/Key Performance Indicators (KPIs). Effective analysis of audit metrics and causes of non-compliance