Quality Auditor – GDP & Pharmacovigilance (GVP)

Quality Auditor – GDP & Pharmacovigilance (GVP)

Global Pharmaceutical Company | GxP Auditing | GDP & Pharmacovigilance

We are partnering with a global pharmaceutical organisation seeking an experienced Quality Auditor with expertise in Good Distribution Practice (GDP) and Pharmacovigilance (PV/GVP) to join its corporate Quality function.

This international position offers responsibility for conducting and coordinating GxP audits, managing supplier qualification activities and ensuring regulatory compliance across global pharmaceutical operations and external partners.

Key Responsibilities

• Plan, coordinate and conduct GDP, Pharmacovigilance and other assigned GxP audits across external suppliers, service providers, manufacturing sites, affiliates and corporate functions.
• Manage assigned audits end-to-end, including scheduling, preparation, execution, reporting and follow-up.
• Support the development and maintenance of annual, risk-based corporate GDP/PV and internal audit programmes.
• Manage and oversee subcontracted GxP audits, ensuring appropriate documentation and follow-up.
• Evaluate and qualify vendors, subcontractors and outsourced service providers, supporting ongoing monitoring and compliance oversight.
• Conduct supplier risk assessments and contribute to annual vendor risk reviews, adapting audit priorities according to identified risks.
• Maintain audit records, supplier qualification documentation and associated quality information within the electronic QMS.
• Monitor changes in global and European GxP regulations, evaluate their potential impact and recommend appropriate compliance improvements.
• Develop audit-related KPIs, support continuous improvement initiatives and contribute to regulatory training activities.
• Collaborate with international Quality, Pharmacovigilance, Supply Chain and other relevant business functions.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Engineering or a related scientific discipline.
• 5+ years of experience in GxP audit management, with demonstrated expertise in Pharmacovigilance and GDP auditing.
• 5+ years of experience in Quality Assurance, Compliance or related functions within a regulated GxP environment.
• Strong working knowledge of European pharmaceutical regulations, GxP quality systems and regulatory compliance requirements.
• Demonstrated experience in audit methodologies, supplier qualification, quality risk management and vendor oversight.
• Ability to independently manage audit activities and collaborate with international, cross-functional stakeholders.
• Excellent communication, organisation and problem-solving skills.
• Fluent written and spoken English.
• Willingness to travel internationally for approximately 30–50% of working time.

Desirable Experience

• Experience auditing pharmaceutical distribution networks, Pharmacovigilance systems and outsourced service providers.
• Exposure to international regulatory frameworks, including FDA, Health Canada, PMDA and ANVISA.
• Familiarity with electronic Quality Management Systems, including Ennov or equivalent platforms (e.g Veeva Vault).
• Professional certifications in Quality, GxP auditing, GDP or Pharmacovigilance.
• Additional language capabilities, including French or Spanish.

The Opportunity

This is an opportunity to play a key role within a global pharmaceutical Quality function, with substantial international exposure and responsibility for maintaining compliance across a diverse network of partners and service providers.

The position offers a combination of hands-on auditing, risk-based quality oversight, supplier qualification and cross-functional collaboration within an international pharmaceutical environment.

Interested? Apply to learn more about the opportunity.