Quality Compliance Officer and Responsible Person (RP)
Norgine · Copenhagen, Capital Region of Denmark, Denmark
About The Role
About Norgine
At Norgine, we transform lives through innovative healthcare solutions. For over a century, we have partnered across Europe to bring life-changing medicines and medical devices to patients who need them. We are guided by our values to Drive , Dare and Develop , creating an environment where people take ownership, challenge boundaries and support each other to succeed.
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.
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.
Why Join Norgine?
Norgine offers more than a role; we offer a 3D career where you can Drive impact, Dare to innovate and Develop your potential in a collaborative, inclusive environment focused on improving patient outcomes.
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