Quality Assurance Manager

About the role

Pfizer is looking for a Quality Assurance Manager to uphold its quality and safety standards for medicinal products. The role covers compliance with the Board of Health (BoH) regulations, product quality and compliance of authorised activities, and oversight of quality operations across the country. It is a hybrid position.

Key responsibilities

• Lead moderately complex projects, operate independently in ambiguous situations and resolve moderately complex problems
• Maintain compliance with BoH regulations and assess new local regulatory requirements; implement procedures on time and monitor KPIs
• Support preparation of GDP and MAH regulatory inspections and internal audits, and ensure self-inspections are carried out regularly
• Manage planned, permanent and temporary changes to GxP-related activities
• Investigate deviations, implement local actions such as recalls and CAPAs, and notify senior managers of significant deviations
• Handle product complaints and perform local release of incoming finished products before distribution
• Oversee repackaging and relabelling contractors, including their approvals and releases
• Manage services and contractor quality, maintain quality agreements, coordinate vendor audits and track the CAPA plan

Required profile

• University degree in pharmaceutical science or another scientific discipline
• Knowledge of pharmaceutical legislation and GDP
• Fluency in written and spoken Slovenian and English; additional languages are an asset
• Hybrid work arrangement

Required skills

• SAP experience
• Project management and independent leadership
• Analytical and problem-solving skills
• Negotiation and communication skills