Senior Quality Specialist, Client Quality Management

About the role

The Senior Quality Specialist will lead the implementation and maintenance of the quality system for assigned client projects, ensuring compliance with global pharmacovigilance regulations, PrimeVigilance standards and client requirements.

Key responsibilities

• Oversee all client‑quality activities, working with Quality Management, QA and Audit teams to enforce the Quality Management System.
• Create and maintain project‑specific quality plans, training matrices and SOP documentation.
• Review regulatory intelligence reports, assess impact on projects and ensure procedures align with global guidelines.
• Manage audit preparation, host client audits, coordinate responses to findings and keep the project inspection‑ready.
• Monitor project metrics, KPIs and corrective actions, performing final quality reviews on processed cases each month.

Required profile

• Life Sciences degree.
• Significant pharmacovigilance experience with quality and compliance in a GxP environment.
• Strong organisational, detail‑oriented and communication abilities.
• Proficient IT skills.

Required skills

• Pharmacovigilance
• GxP compliance
• Quality Management
• IT proficiency