GVP Auditor - Pharmacovigilance Quality Assurance

CSL; Maidenhead; On-site; GBP 45,000 - 65,000; Full time

Job summary

CSL is seeking an experienced GVP Auditor to join our Research & Development Quality audit program in the United Kingdom. You will execute the global audit plan, assess safety data accuracy, and ensure compliance with regulatory standards across external partners and internal safety functions.

This role requires travel up to 50% and collaboration with multinational stakeholders. The ideal candidate has QA experience in a GVP-regulated environment, strong audit and analytical skills, and the

Qualifications

• BS degree in a relevant science.
• Quality Assurance experience in a GVP-regulated environment.
• Experience in audit and inspection management.
• Strong interpersonal and negotiation skills with multinational stakeholders.

Responsibilities

• Audit Execution: conduct external audits of PV vendors and internal self-inspections of safety processes, systems, and affiliates.
• Reporting & Risk Categorization: issue Audit Reports with findings and CAPA recommendations.
• Trend Analysis: identify non-compliance trends and systemic risks in PV and communicate to management.
• Continuous Improvement: help update SOPs and develop risk-based, compliant audit solutions.
• Regulatory Knowledge: stay current with global GVP regulations and EMA guidelines.

Skills

Audit Expertise

Communication Skills

Organizational Agility

Education

BS degree in Biological Sciences / Pharmacy

Job description

CSL is seeking an experienced GVP Auditor to join our Research & Development Quality audit program in the United Kingdom. You will execute the global audit plan, assess safety data accuracy, and ensure compliance with regulatory standards across external partners and internal safety functions.

This role requires travel up to 50% and collaboration with multinational stakeholders. The ideal candidate has QA experience in a GVP-regulated environment, strong audit and analytical skills, and the