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Norgine

European specialty pharma focused on gastroenterology

Process Compliance Lead

Regulatory & Quality (Life Sciences)Posted on Nov 6
Full-timeHengoed, UKNo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree or equivalent level is required.
  • Strong experience within quality, compliance or regulated operations, including the ability to advise others on complex situations.
  • Experience leading or overseeing compliance programmes, audits, quality reviews, investigations, corrective and preventive actions, and risk management activities.
  • Strong understanding of Good Manufacturing Practice, regulatory expectations, Pharmaceutical Quality Systems and compliance controls.
  • Experience using quality and operational data, key performance indicators and trend analysis to identify risk and drive continuous improvement.
  • Experience supervising and directing people and resources to deliver defined outcomes.
  • Experience with quality assurance methodologies, compliance systems, policies and procedures.
  • Ability to manage complexity, establish priorities and drive sustainable process improvements.
  • Strong stakeholder management, planning and communication skills.

Responsibilities

  • Lead the Process Compliance programme, setting priorities, governance frameworks and improvement strategies across Manufacturing Operations.
  • Establish compliance assurance processes using audits, self-inspections and quality reviews to identify risk and support inspection readiness.
  • Provide governance and oversight of quality events, investigations, corrective and preventive actions, and quality system actions, ensuring sustainable corrective actions are implemented.
  • Identify, assess and manage compliance risks, escalating significant issues and ensuring effective mitigation.
  • Lead compliance improvement initiatives that strengthen quality system effectiveness and operational performance.
  • Develop and monitor key performance indicators, trends and compliance performance measures to support informed decision-making.
  • Lead and develop the Process Compliance team, ensuring capability and priorities are aligned with compliance and business objectives.

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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