Quality Compliance Officer & Responsible Person (RP)

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

Transforming Lives Through Quality and Compliance

At Norgine, we have been transforming people’s lives for over a century. We are a leading European specialist pharmaceutical company, combining deep expertise, an integrated infrastructure, and strong partnerships to bring life-changing products to patients.

Our values are at the heart of everything we do:

Drive - We take ownership, make timely decisions, and deliver results.
Dare - We challenge respectfully, encourage innovation, and embrace new opportunities.
Develop - We collaborate, value different perspectives, and help people reach their full potential.

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.

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.

Why Join Norgine?

At Norgine, we support multidimensional careers where people are encouraged to dare, drive and develop. You’ll join a collaborative organisation committed to improving patients’ lives while providing opportunities for professional growth, learning, and meaningful impact.

Norgine is an equal opportunities employer and values diversity. We welcome applications from all qualified candidates regardless of background, identity, or experience.