Senior Auditor for Good Clinical Practices and Pharmacovigilance
hace 2 semanas
As a Senior Auditor for Good Clinical Practices and Pharmacovigilance, you will be responsible for leading and supporting independent GCP/PV audits to assess compliance with applicable regulations, standards, and guidance documents. You will review and approve corrective action plans, ensure alignment with the company's strategic direction, and provide consultation to business units through risk-based assessments.
About the Role
This is a key position in our Global GxP Audit team, responsible for executing the risk-based Unified Quality Audit Plan (UQAP) and ensuring timely execution of comprehensive and targeted audits. You will work closely with management to develop a robust, effective, and compliant GCP/PV audit plan for Novartis.
Key Responsibilities
• 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.
• 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.
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