Quality Compliance Officer and Responsible Person (RP)

Quality Compliance Officer and Responsible Person (RP)

Norgine

Copenhagen, Denmark

The Opportunity

We are looking for a Quality Compliance Officer and Responsible Person (RP) to provide quality oversight and ensure compliance with Wholesale Distribution Licence requirements and Good Distribution Practice (GDP) regulations. This role is critical in maintaining product quality, patient safety and regulatory compliance across one or more Norgine entities.

Key Responsibilities

• Act as the Quality Compliance Officer and Responsible Person (RP) for Wholesale Distribution Licence activities in line with GDP requirements.
• Ensure compliance with applicable regulatory and quality standards.
• Support inspection readiness and host regulatory inspections.
• Oversee third-party distribution providers and outsourced activities.
• Manage quality incidents, compliance risks and product recall activities.
• Develop and maintain policies, procedures and training programmes.
• Provide expert advice on regulatory and compliance matters.
• Partner with internal and external stakeholders to drive continuous improvement.

Requirements

Skills & Experience

• Scientific Bachelor's degree or equivalent qualification.
• Eligible for immediate registration as a Responsible Person.
• Strong experience within GDP-regulated pharmaceutical environments.
• Experience conducting audits and supporting regulatory inspections.
• Sound knowledge of quality systems, compliance frameworks and risk management.
• Strong communication, planning and organisational skills.
• Ability to influence stakeholders and make effective decisions in complex situations.

Success at Norgine

The ideal candidate will demonstrate our values by:

• Drive: Taking ownership, delivering results and making timely decisions.
• Dare: Challenging constructively, embracing innovation and finding better ways of working.
• Develop: Collaborating effectively, valuing different perspectives and helping others succeed.