AssureBio is supporting a leading global pharmaceutical organisation in hiring a Global GCP & GVP Quality Auditor to strengthen its global audit and inspection programme across Clinical Development and Pharmacovigilance.
This role is ideal for an experienced GxP professional with a strong foundation in GCP and GVP auditing who thrives in a collaborative, international environment. You’ll lead and execute audits, support inspection readiness, and help maintain the highest levels of Quality and regulatory compliance across multiple GxP domains.
Key Responsibilities
* Audit Leadership: Plan, conduct, and report GCP and GVP audits across investigator sites, CROs, vendors, and internal functions.
* Regulatory Compliance: Assess compliance with ICH-GCP, EU GVP, and relevant global regulations (FDA, EMA, MHRA).
* Inspection Readiness: Coordinate and support pre-inspection preparation and post-inspection follow-up activities.
* CAPA Oversight: Review audit findings, evaluate CAPA responses, and monitor completion to ensure effectiveness.
* Continuous Improvement: Identify systemic risks, drive process enhancements, and contribute to Quality Systems evolution.
* Cross-Functional Collaboration: Work closely with QA, Safety, Regulatory Affairs, and R&D to strengthen Quality culture and readiness.
Experience & Qualifications
* 5+ years of experience in GCP/GVP auditing or Clinical/Pharmacovigilance Quality Assurance.
* Strong understanding of ICH-GCP, EU GVP, and international regulatory frameworks.
* Hands-on experience conducting and hosting audits and Health Authority inspections.
* Excellent analytical, reporting, and stakeholder management skills.
* Degree in Life Sciences, Pharmacy, or a related discipline (auditor certification preferred).