Quality Compliance Officer & Responsible Person (RP)
Norgine · Amsterdam
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 Norgine Global 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.
- Provide leadership and support to the Global Distribution Quality team for ongoing operations and business project deployment, ensuring compliant and effective delivery, and act as the primary point of contact for the CHC Business Unit.
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 external and internal GDP audits and leading 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.
Benefits
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.