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Norgine

European specialty pharma focused on gastroenterology

Validation Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeHengoed, UKNo salary listedIn-person

About the Job

Requirements

  • Significant experience within the pharmaceutical or medical device industry.
  • Proven validation management and project leadership experience.
  • Experience leading, coaching, and developing teams.
  • Strong knowledge of validation lifecycle management and quality systems.
  • Working knowledge of ICH Q8, ICH Q9, GAMP, current Good Manufacturing Practice, and European Union and United States Food and Drug Administration regulatory requirements.
  • Expertise in quality assurance and validation.
  • Risk management and analytical problem-solving skills.
  • Strong communication, influencing, and stakeholder management abilities.
  • Ability to make sound decisions in complex environments.
  • Effective reporting, negotiation, and presentation skills.
  • Commitment to continuous improvement and operational excellence.
  • Degree equivalent in a scientific or engineering discipline such as Chemistry, Biology, Process Engineering, Pharmaceutical Sciences, or Medical Technology.

Responsibilities

  • Lead and develop the site validation strategy, programmes, policies, and procedures.
  • Ensure validation activities comply with Good Manufacturing Practice requirements, regulatory expectations, and industry best practice.
  • Oversee qualification and validation activities for facilities, utilities, equipment, computerised systems, cleaning processes, and manufacturing processes.
  • Review and approve validation documentation and key deliverables.
  • Provide oversight of deviations, investigations, corrective and preventive actions, change controls, audits, and inspections.
  • Monitor validation performance, identify risks and improvement opportunities, and communicate outcomes to senior stakeholders.
  • Build strong partnerships across Quality, Operations, Engineering, and Regulatory functions.

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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