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Norgine

European specialty pharma focused on gastroenterology

Facility Compliance Lead

Facilities ManagementConfirmed live in the last 24 hours
Full-timeHengoed, UKNo salary listedIn-person

About the Job

Requirements

  • Strong experience within engineering, facilities or quality compliance in a regulated environment.
  • In-depth understanding of engineering standards and compliance.
  • Strong knowledge of relevant policies, regulations and quality management principles.
  • Experience supporting regulatory and customer audits, with knowledge relevant to Good Manufacturing Practice (GMP), the U.S. Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA), and International Organization for Standardization (ISO) requirements.
  • Experience managing maintenance, calibration, compliance or preventive planned maintenance (PPM) systems.
  • Knowledge of quality assurance, project quality management and compliance systems.
  • Strong risk management, investigation and continuous improvement capabilities.
  • Experience supervising and directing people and resources to deliver results within defined timescales.
  • Computer literacy, including working knowledge of Microsoft Office and a preventive planned maintenance (PPM) system.
  • Strong communication, stakeholder management, planning and decision-making skills.

Responsibilities

  • Lead the site's Facility Compliance programme, setting compliance priorities, governance and improvement strategies.
  • Lead and develop the Engineering Compliance team, maintaining high standards of accountability and capability.
  • Oversee preventive maintenance and calibration programmes to ensure activities remain within required schedules and compliance tolerances.
  • Act as the Engineering representative during internal and external audits, inspections and regulatory reviews.
  • Monitor compliance performance through key performance indicators, trend analysis and governance reporting, identifying and escalating emerging risks.
  • Maintain oversight of engineering quality systems, procedures, records and controlled documentation.
  • Own computerized maintenance management system (CMMS) governance, data integrity and compliance.
  • Lead compliance investigations, risk assessments, change controls and corrective actions.
  • Work closely with Quality on corrective and preventive actions (CAPAs), audit observations and remediation activities.
  • Provide compliance oversight for facility improvements, remediation and capital projects.
  • Ensure contractor activities meet appropriate safety, quality and compliance standards.

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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