Global GVP Auditor — Pharmacovigilance & Compliance

CSL; Boca Raton (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

CSL Vifor in Boca Raton, FL seeks a GVP Auditor to execute our global audit plan, ensuring the accuracy of safety data and compliance with regulatory standards. You will audit external PV vendors and internal safety processes, identifying findings and non-compliance trends affecting the PV system.

Qualified candidates will have QA experience in a GVP environment, strong analytical skills, and the ability to develop corrective actions with stakeholders across regions.

Qualifications

• Academic background in biology, pharmacy or related science.
• Experience with QA in a GVP-regulated environment.
• Audit and inspection management knowledge in pharmacovigilance.
• Strong interpersonal and negotiation skills for multinational teams.

Responsibilities

• Audit external pharmacovigilance vendors and internal safety processes.
• Develop and issue audit reports with risk-based CAPA recommendations.
• Identify non-compliance trends to support PV system health.
• Support SOP improvements and risk-based compliant solutions.
• Maintain up-to-date knowledge of global GVP regulations and EMA guidelines.

Skills

GVP auditing

Pharmacovigilance

Regulatory compliance

Stakeholder communication

Education

BS degree in biological science or pharmacy

Job description

CSL Vifor in Boca Raton, FL seeks a GVP Auditor to execute our global audit plan, ensuring the accuracy of safety data and compliance with regulatory standards. You will audit external PV vendors and internal safety processes, identifying findings and non-compliance trends affecting the PV system.

Qualified candidates will have QA experience in a GVP environment, strong analytical skills, and the ability to develop corrective actions with stakeholders across regions.