Full-Time

Quality Officer / Senior Quality Officer

Norgine

Norgine

1,001-5,000 employees

European specialty pharma focused on gastroenterology

No salary listed

Hengoed, UK

In Person

Bachelor's

Category
Manufacturing Quality & Test (1)
Required Skills
Quality Assurance (QA)
Risk Management
Data Analysis

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Requirements
  • Experience working within a Quality Assurance, Quality Control or regulated manufacturing environment.
  • Understanding of Good Manufacturing Practice, quality systems and compliance requirements.
  • Ability to analyse data, investigate issues and maintain accurate documentation.
  • Strong organisational, planning and communication skills.
  • A proactive approach to problem solving and continuous improvement.
  • Demonstrable experience working independently within a pharmaceutical or highly regulated environment.
  • Experience supporting audits, inspections and Quality Management Systems.
  • Experience coaching, supervising or providing technical guidance to colleagues.
  • Strong understanding of quality compliance, risk management, validation and regulatory expectations.
  • A degree in a scientific or engineering discipline, or equivalent relevant experience.
Responsibilities
  • Perform quality assurance activities and review quality-related documentation.
  • Support the Quality Management System, ensuring procedures and records remain compliant.
  • Conduct quality investigations, testing reviews and compliance activities.
  • Analyse quality data and identify trends, risks and improvement opportunities.
  • Support internal and external audits and inspection readiness.
  • Ensure compliance with Good Manufacturing Practice, regulatory requirements and site procedures.
  • Contribute to continuous improvement, change management and quality initiatives.
  • Lead and coordinate shift-based quality activities.
  • Provide technical guidance, coaching and on-the-job training for Quality Assurance colleagues.
  • Support audit management, supplier quality activities and regulatory inspections.
  • Review and approve quality documentation, validation records and compliance reports.
  • Drive quality performance through key performance indicator monitoring, trend analysis and risk management.
  • Escalate quality and compliance issues appropriately and support resolution activities.

Norgine is a European specialty pharmaceutical company focused on gastroenterology. It develops, markets, and distributes prescription medicines, including MOVICOL, an osmotic laxative that draws water into the stool to relieve constipation. Its products target GI disorders and are sold mainly in Europe, leveraging a long family-ownership legacy until 2022 when Goldman Sachs Asset Management's private equity arm acquired a majority stake to speed growth through acquisitions and new products. The goal is to expand its platform by adding new therapies and strategic acquisitions to strengthen its position in the European market.

Company Size

1,001-5,000

Company Stage

Acquired

Total Funding

N/A

Headquarters

Amsterdam, Netherlands

Founded

1906

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Simplify Jobs

Simplify's Take

What believers are saying

  • PEDMARQSI gained Australia TGA registration on 5 May 2026, expanding pediatric oncology reach.
  • European Commission approved XOLREMDI in 2026, opening WHIM syndrome sales across Europe.
  • Theravia closed on 14 August 2025, widening Norgine's rare-disease portfolio and integration upside.

What critics are saying

  • MHRA suspended Norgine Limited's manufacturer/importer licence on 31 July 2026 after GMP failures.
  • TGA recalled MOVICOL batches on 19 August 2026, exposing quality-control breakdowns across core products.
  • If GMP problems persist, regulators shut Norgine manufacturing and partners reroute critical supply chains.

What makes Norgine unique

  • Norgine commercializes rare-disease drugs across Europe, Australia, and New Zealand, not discovery research.
  • January 2025 XOLREMDI and 2026 PEDMARQSI approvals show unusually strong regulatory execution.
  • Hengoed manufacturing and integrated commercialization give Norgine control over supply, access, and launches.

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Benefits

Training Programs

Company News

PR Newswire
May 5th, 2026
Norgine's PEDMARQSI gains Australian approval to prevent hearing loss in children receiving cisplatin

Norgine has received Australian Therapeutic Goods Administration registration for PEDMARQSI (sodium thiosulfate anhydrous) for preventing cisplatin-induced hearing loss in children aged one month to under 18 years with localised, non-metastatic solid tumours. PEDMARQSI is the first and only treatment registered in Australia for preventing cisplatin-induced ototoxicity in paediatric patients. Cisplatin chemotherapy carries substantial risk of permanent hearing loss, which can affect speech development, education and quality of life in children. The TGA registration is based on data from two Phase 3 clinical trials. The approval follows previous authorisations in Europe, the United Kingdom and Switzerland. PEDMARQSI is not currently included on Australia's Pharmaceutical Benefits Scheme. Norgine is a European specialty pharmaceutical company with 1,500 employees generating approximately $650 million in annual sales.

PR Newswire
Apr 29th, 2026
European Commission approves XOLREMDI, first authorised treatment for WHIM syndrome in the EU

Norgine has received European Commission marketing authorisation for XOLREMDI (mavorixafor), the first approved treatment for WHIM syndrome in the European Union. The approval, granted under exceptional circumstances, follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use. XOLREMDI is indicated for patients aged 12 and older with WHIM syndrome, an ultra-rare primary immunodeficiency that impairs white blood cell release from bone marrow, increasing infection risk. The approval is supported by results from a pivotal Phase 3 trial involving 31 patients. Norgine will commercialise mavorixafor across Europe, Australia and New Zealand under a licensing agreement with X4 Pharmaceuticals announced in January 2025. The company will handle market access and commercialisation, whilst X4 will manufacture and supply the treatment.

PR Newswire
Mar 26th, 2026
Norgine's PEDMARQSI approved in Switzerland to prevent cisplatin-induced hearing loss in children

Norgine has announced that Swissmedic has approved PEDMARQSI (sodium thiosulfate solution for infusion) for preventing cisplatin-induced hearing loss in children aged 1 month to under 18 years with localised, non-metastatic solid tumours. It becomes the first and only treatment authorised in Switzerland for this indication. The approval is based on two open-label, randomised Phase 3 trials, SIOPEL 6 and COG ACCL0431, which showed approximately 50% reduction in cisplatin-induced ototoxicity compared with cisplatin alone, whilst maintaining chemotherapy efficacy. PEDMARQSI previously received paediatric use marketing authorisation from the European Medicines Agency in May 2023 and national marketing authorisation in the UK. Amsterdam-based Norgine is a mid-sized pharmaceutical company generating approximately $650 million in annual sales.

Business News Wales
Mar 6th, 2026
Norgine invests $29.2M to create 44 jobs at Wales pharma plant

Pharmaceutical company Norgine is investing £23 million and creating 44 jobs at its manufacturing plant in Hengoed, Caerphilly. The expansion will increase warehousing and production space to meet growing demand for essential medicines across the UK. The investment has been enabled by the UK Government's Life Sciences Innovative Manufacturing Fund, part of the Life Sciences Sector Plan. Wales's life sciences sector generated over £3.5 billion in turnover and employed more than 13,000 people across 280 companies in 2023/24. Norgine has operated in Wales for 60 years and partners with Cardiff University and regional colleges for talent development. Secretary of State for Wales Jo Stevens announced the expansion whilst launching a new international programme to attract further investment to Wales, which secured nearly 5% of UK inward investment projects in 2024/25.

Ochre Digi Media Pvt Ltd.
Apr 17th, 2025
Norgine Expands Rare Disease Portfolio with Acquisition of Theravia

Norgine expands rare disease portfolio with acquisition of Theravia.