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Quality Compliance Officer & Responsible Person (RP)

Norgine

Amsterdam
Full-time
5-10 years experience
Hybrid

Key Skills

Good Distribution Practice
GDP
Quality compliance
Regulatory inspections
Auditing
Risk management
Quality systems
Stakeholder management
Policy development
Training program management
Product recall
Wholesale distribution
Leadership
Communication
Organizational skills
Decision making

Job Description

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.
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.

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.

Core Responsibilities

The Quality Compliance Officer and Responsible Person will oversee wholesale distribution activities to ensure compliance with GDP regulations and regulatory standards. They will manage quality incidents, lead regulatory inspections, and provide expert guidance to internal and external stakeholders.

Requirements

Candidates must hold a scientific bachelor's degree and be eligible for immediate registration as a Responsible Person. Strong experience in GDP-regulated pharmaceutical environments and conducting audits is required.

Benefits

  • Professional growth opportunities
  • Learning and development
  • Collaborative environment

About Norgine

Industry: Pharmaceutical Manufacturing

Company size: 1,001-5,000 employees

Norgine is a uniquely positioned, specialty pharmaceutical and consumer healthcare company, with more than €500 million of annual revenues and a 120-year track record of bringing life-changing products to patients and consumers across their core markets of Western Europe, Australia, and New Zealand. Today’s Norgine is a nimble, innovative, and high-performing company that has been transformed by a relentless focus on operational excellence to do the right thing by patients, push boundaries, and take strides into new therapeutic areas. The company’s integrated approach – strong commercial capabilities, deep medical, regulatory and clinical expertise, in-house manufacturing, robust supply networks, and best-in-class enabling functions – ensures delivery of high-quality, transformative medicines quickly and effectively to more than 25 million patients annually.

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