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Norgine

European specialty pharma focused on gastroenterology

Quality Compliance Officer & Responsible Person

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeAmsterdam, NetherlandsNo salary listed

About the Job

Requirements

  • A scientific Bachelor's degree or equivalent qualification is required.
  • Eligibility for immediate registration as a Responsible Person is required.
  • Strong experience within GDP-regulated pharmaceutical environments is required.
  • Experience conducting external and internal GDP audits and leading regulatory inspections is required.
  • Sound knowledge of quality systems, compliance frameworks, and risk management is required.

Responsibilities

  • Act as the Quality Compliance Officer and Responsible Person 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.

About the Company

Norgine

European specialty pharma focused on gastroenterology

Norgine is a European specialty pharmaceutical company that develops, markets, and distributes prescription medicines for gastroenterology. Its products, such as MOVICOL, work as osmotic laxatives by drawing water into the stool to soften it and increase bowel movements, and are sold across Europe. The company distinguishes itself with a long, family-led history and deep GI expertise, now backed by Goldman Sachs Asset Management’s private equity arm to pursue growth through acquisitions and new product development. Its goal is to expand its GI-focused portfolio and strengthen its European market position through strategic acquisitions and new therapies.

Company size
1,001-5,000
Company stage
Acquired
Total funding
Not listed
Headquarters
Amsterdam, Netherlands
Founded
1906

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