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 and Responsible Person (RP) - Leuven Hybrid
Serve as the Responsible Person for pharmaceutical distribution operations at Norgine, ensuring GDP compliance, inspection readiness, and quality oversight. Support patient safety through effective regulatory governance and continuous improvement.
Description
- Serve as the Responsible Person for designated Norgine entities and Wholesale Distribution Licences
- Maintain compliance with EU GDP requirements and other applicable regulations
- Lead inspection-readiness initiatives and assist with 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 compliance requirements
- Advance continuous improvement across quality and distribution processes
Requirements
- Bachelor’s degree in a scientific discipline or an equivalent qualification
- Be eligible for immediate registration as a Responsible Person
- Professional experience in pharmaceutical environments regulated under GDP
- Background in conducting audits and supporting regulatory inspections
- Strong understanding of quality systems, regulatory compliance, and risk management
- Highly effective planning, organisational, and communication abilities
- Sound judgement when making decisions and resolving complex issues
- Demonstrated ownership and reliable delivery of results
- Ability to establish trust through integrity and accountability
- Effective collaboration across functions and cultural backgrounds
- Confidence to challenge constructively and pursue innovative solutions
- Clear communication with diverse stakeholder groups
Benefits
- Opportunities for professional development, learning, and meaningful contribution
- Collaborative workplace focused on improving patients’ lives
- Equal-opportunity employer that values diversity