Quality Compliance Officer & Responsible Person (RP)

Quality Compliance Officer & Responsible Person (RP)

Norgine

Leuven, Belgium

We are looking for a Responsible Person to provide quality oversight and ensure compliance with Wholesale Distribution Licence requirements and Good Distribution Practice (GDP) regulations. This role plays a critical part in maintaining the highest standards of quality, compliance, and patient safety.

Requirements

Responsibilities:

• Act as the Responsible Person for designated Norgine entities and Wholesale Distribution Licences.
• Ensure compliance with EU GDP requirements and applicable regulations.
• Lead inspection readiness activities and support regulatory inspections.
• Oversee outsourced distribution activities and third-party compliance.
• Support product recalls, investigations, audits, and risk management activities.
• Develop and maintain quality procedures, policies, and training programmes.
• Provide expert advice to internal stakeholders on quality and compliance matters.
• Drive continuous improvement across quality and distribution processes.

Skills and Experience

• Scientific Bachelor's degree or equivalent qualification.
• Eligible for immediate registration as a Responsible Person.
• Experience within pharmaceutical GDP-regulated environments.
• Experience conducting audits and supporting regulatory inspections.
• Strong knowledge of quality systems, regulatory compliance, and risk management.
• Excellent planning, organisation, and communication skills.
• Ability to make sound decisions and manage complex issues effectively.

Success in This Role

You will thrive in this position if you:

• Take ownership and deliver results.
• Build trust through integrity and accountability.
• Collaborate effectively across functions and cultures.
• Challenge constructively and seek innovative solutions.
• Communicate clearly with a wide range of stakeholders.