Auditor - GVP

Overview

Quality in a globalized drug safety network is a matter of operational resilience as much as regulatory mandate. This role serves as a GVP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of safety data and compliance with legal and corporate standards.

• Conduct assigned external audits of pharmacovigilance vendors and service providers.
• Conduct internal self‑inspections of safety processes, systems, and affiliates, including local and regional safety officers.
• Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to drug safety.
• Identify non‑compliance trends and systematic risks within the PV discipline, communicating findings to line management and functional leads to support PV system health.
• Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk‑based, compliant solutions that ensure compliance with EMA Guidelines on Good Pharmacovigilance Practices (GVP Modules) and applicable global and local regulatory requirements.
• Maintain up‑to‑date knowledge of global GVP regulations and industry trends to support internal quality and compliance.

Academic Background: BS degree in a relevant biological science, pharmacy, or related science discipline.

Professional

Experience:

Quality Assurance experience within a GVP‑regulated environment, demonstrating a strong understanding of drug safety operations and regulatory frameworks.

Audit Expertise: Experience in audit and inspection management, with a clear understanding of the requirements for quality assurance in the pharmacovigilance discipline.

Communication

Skills:

Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational teams and external stakeholders across different regions.

Working Knowledge of:

• ICH E2D(R1), E2A, E2B(R3), E2C(R2), E2F, and GXP Guidelines.
• 21 CFR Part 314.80 (for drugs), Part 600 Subpart D (for biologics) and Part 4 (combination product/duplicate reporting prevention).
• Directive 2001/83/EC (as amended), Regulation (EC) No 726/2004, Commission Implementing Regulation (EU) No 520/2012.
• EMA GVP Modules (I–XVI + product/population‑specific modules).

Organizational Agility: Strong analytical and problem‑solving skills, ability to work with limited supervision, manage a schedule that includes up to 50% travel.

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit accessibility‑statement.