QPI Expert – Quality & Pharmacovigilance

About the role

The QPI Expert will support the Head of Quality and Process Improvement in developing, implementing and maintaining the corporate quality system for a pharmaceutical organization. This role focuses on both quality management and pharmacovigilance, ensuring compliance with ISO 9001, ICH, GCP and local regulations.

Key responsibilities

• Collaborate with senior quality leadership to evolve the corporate quality system.
• Develop and maintain the ProductLife Group quality management system and controlled document system (SOPs, WPDs, forms).
• Ensure accurate, timely entry of data into quality trackers for automated reporting.
• Identify process inefficiencies and propose improvement solutions.
• Provide quality verification, corrective action plans, and continuous‑improvement guidance.
• Manage the annual risk‑based audit program and act as primary contact for client auditors and vendors.
• Oversee vendor, supplier and subcontractor quality activities and audits.
• Maintain and enhance training programs and develop quality metrics with other departments.
• Represent quality at Global Quality Management Team meetings.

Required profile

• Bachelor’s degree or higher in a scientific field, or equivalent experience.
• Minimum 8 years of experience in a quality role within the pharmaceutical industry.
• Knowledge or experience in pharmacovigilance (PV) is required.

Required skills

• Knowledge of ISO 9001 quality management standards.
• Familiarity with ICH guidelines and Good Clinical Practice (GCP).
• Experience with controlled document systems (SOPs, WPDs, templates).