Norgine is a European specialist pharmaceutical company with a history dating back to 1906. Its team acquires, develops, and commercializes medicines through a global network of partnerships, with particular expertise in gastroenterology and hepatology. The company’s products reach around 25 million patients worldwide each year, supported by more than 1,400 employees and over €500 million in net product sales. Norgine works with partners through licensing, acquisitions, and special purpose vehicles, while reinvesting in the development of future medicines.
Quality Compliance Officer – Responsible Person at Norgine (Hybrid)
Serve as the Responsible Person for Norgine’s pharmaceutical distribution operations, ensuring GDP compliance, inspection readiness, and effective quality oversight. Support patient safety through audits, risk management, recalls, and regulated wholesale distribution.
Description
- Serve as the Responsible Person for designated Norgine entities and Wholesale Distribution Licences
- Maintain compliance with EU GDP standards and other applicable regulations
- Lead inspection-readiness programmes and support regulatory inspections
- Oversee outsourced distribution operations and third-party compliance
- Support product recalls, investigations, audits, and risk-management activities
- Create and maintain quality procedures, policies, and training programmes
- Advise internal stakeholders on quality and regulatory compliance matters
- Advance continuous improvement across quality and distribution processes
Requirements
- Bachelor’s degree in a scientific discipline or an equivalent qualification
- Eligible for immediate registration as a Responsible Person
- Professional experience in pharmaceutical GDP-regulated environments
- Experience conducting audits and supporting regulatory inspections
- Strong understanding of quality systems, regulatory compliance, and risk management
- Excellent planning, organisational, and communication abilities
- Sound judgement and the ability to manage complex issues effectively
- Demonstrated ownership and results-focused execution
- Integrity and accountability in building trust
- Effective collaboration across functions and cultures
- Constructive challenge and an innovative approach to problem-solving
- Clear communication with diverse stakeholder groups
Benefits
- Professional development, learning, and opportunities to make a meaningful impact
- A collaborative organisation focused on improving patients’ lives
- An equal-opportunity workplace that values diversity