GDP Quality & Compliance Lead – Regulatory Readiness

Norgine; Uxbridge; On-site; GBP 65,000 - 90,000; Full time

Job summary

Norgine is seeking a Responsible Person to provide quality oversight and ensure GDP compliance across designated entities and Wholesale Distribution Licences. The role focuses on maintaining high standards of quality, compliance and patient safety.

The successful candidate will lead inspection readiness, manage external audits, and drive continuous improvement in quality and distribution processes while collaborating with internal stakeholders across functions.

Qualifications

• Bachelor’s degree or equivalent in a scientific field.
• Experience in pharmaceutical GDP environments.
• Experience conducting audits and supporting regulatory inspections.
• Strong knowledge of quality systems and regulatory compliance.
• Excellent planning and communication skills.

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.
• 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

Quality systems

Regulatory compliance

Audits

Risk management

Communication

Decision making

Planning & organisation

Education

Bachelor's degree in a scientific field

Job description

Norgine is seeking a Responsible Person to provide quality oversight and ensure GDP compliance across designated entities and Wholesale Distribution Licences. The role focuses on maintaining high standards of quality, compliance and patient safety.

The successful candidate will lead inspection readiness, manage external audits, and drive continuous improvement in quality and distribution processes while collaborating with internal stakeholders across functions.