Global GVP Auditor - Pharmacovigilance Compliance

CSL; King of Prussia (PA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

CSL Behring in King of Prussia is seeking an experienced GVP auditor to execute the global pharmacovigilance audit plan within our R&D Quality program. You will audit external partners and internal safety processes to ensure data integrity and regulatory compliance, driving CAPAs and continuous improvement across the safety organization.

You will analyze findings, categorize risk, and collaborate with cross-functional teams to implement corrective actions, with up to 50% travel supporting global

Qualifications

• Academic Background: BS degree in a relevant biological science, pharmacy, or related field.
• Professional Experience: QA in a GVP-regulated environment with drug safety operations understanding.
• Audit Expertise: Experience in audit and inspection management for quality assurance in pharmacovigilance.
• Communication Skills: Excellent interpersonal and negotiation skills with multinational teams.
• Working Knowledge: Familiarity with ICH E2D/E2A/E2B/E2C/E2F and EMA GVP modules plus 21 CFR parts.

Responsibilities

• Audit Execution: conduct external pharmacovigilance audits and internal self-inspections.
• Reporting & Risk Categorization: create audit reports and categorize findings with CAPA recommendations.
• Trend Analysis: identify non-compliance trends and systemic risks in PV.
• Continuous Improvement: help update SOPs and risk-based compliant solutions.
• Regulatory Knowledge: maintain up-to-date knowledge of global GVP regulations and industry trends.

Skills

Quality Assurance in GVP environment

Audit and inspection management

Communication skills

Education

BS degree in biological science, pharmacy, or related field

Job description

CSL Behring in King of Prussia is seeking an experienced GVP auditor to execute the global pharmacovigilance audit plan within our R&D Quality program. You will audit external partners and internal safety processes to ensure data integrity and regulatory compliance, driving CAPAs and continuous improvement across the safety organization.

You will analyze findings, categorize risk, and collaborate with cross-functional teams to implement corrective actions, with up to 50% travel supporting global