Global PV Audit Specialist — GVP & Compliance

CSL Vifor; Waltham (MA); Hybrid; USD 90,000 - 150,000; Full time

Job summary

CSL Vifor is seeking a GVP Auditor to execute the global PV audit plan, ensuring safety data accuracy and compliance with regulatory standards. You will audit external partners and internal safety functions, identify non-compliance trends, and help implement corrective actions to strengthen PV system reliability.

The role requires collaboration with multinational teams, audit management expertise, and continuous improvement of SOPs in line with EMA GVP modules and applicable regulations.

Qualifications

• BS degree in a relevant biological science, pharmacy, or related discipline.
• Quality Assurance experience within a GVP-regulated environment.
• Audit and inspection management in pharmacovigilance.
• Excellent interpersonal and negotiation skills with multinational teams.

Responsibilities

• Audit Execution: Conduct external audits of PV vendors and internal self-inspections.
• Reporting & Risk Categorization: Produce Audit Reports, categorize findings, and recommend CAPAs.
• Trend Analysis: Identify non-compliance trends and systemic risks in PV.
• Continuous Improvement: Improve SOPs and develop risk-based compliant solutions.
• Regulatory Knowledge: Stay current on global GVP regulations and EMA guidelines.

Skills

Audit management

Regulatory knowledge

Communication

Analytical thinking

Education

BS in biological science

Job description

CSL Vifor is seeking a GVP Auditor to execute the global PV audit plan, ensuring safety data accuracy and compliance with regulatory standards. You will audit external partners and internal safety functions, identify non-compliance trends, and help implement corrective actions to strengthen PV system reliability.

The role requires collaboration with multinational teams, audit management expertise, and continuous improvement of SOPs in line with EMA GVP modules and applicable regulations.