Title: Quality Assurance Specialist Company: Ipsen Biopharm Ltd Job Description: We are currently recruiting for a Quality Assurance Specialist to join our Pharmaceutical Development Quality, Global Quality function. This position is based at our Wrexham site and reports directly to the Product and Regulatory Quality Assurance Senior Manager who is based in France. Ipsen is a fast-growing biopharmaceutical group specialising in the development of innovative medicines in oncology, neuroscience, and rare diseases. Our goal is to improve the quality of life of patients through the search for new solutions to targeted disabling diseases. To achieve this goal, Ipsen is committed to the development of its 5,700 employees in 35 countries. Within the Global Pharmaceutical Development organisation (3 European sites and 1 US site), you will actively contribute to the strategy of becoming a center of excellence in the development of biologics, neurotoxins, small molecules and medical devices and strategic partner in the life cycle management of the established products. The main objectives of the position are: QA approval of semi finished products and finished products (small molecules, toxins, medical devices, Ipsen established products) by ensuring the quality of products for clinical trials. Manage and adjudicate on quality deviations by participating in investigations and approving action plans, ensuring proper management of deviations, change controls. Manage efficient quality relationships with contract development and manufacturing organisations (CDMOs) Main duties & responsibilities: Preparation of products certification for clinical trials: Lead and/or perform batch record review and ensure product and production process compliance with appropriate repositories and regulatory requirements. Check or approve the documents needed to manufacture and release batches such as the Product specification files, master batch records, related documents (instructions, forms, development protocol/report, etc.), formal stability batches and clinical batches Manage Quality activities and relationships with CDMOs and service providers. Manage their upgrading on operational quality aspects Manage quality events (deviations, OOS, change control, Complaints, Temperature excursions CAPA’s associated with product development and clinical studies and ensure implementation of corrective and preventive actions Quality support for projects development: As Quality representative in development projects CMC cross functional workstream, ensure Quality support in projects with a high level of autonomy and expertise Ensure definition and compliance of the requirements Ensure the follow-up of the projects for which he/she is responsible with the Product and Regulatory Quality Assurance Senior Manager and the Pharm dev Quality Department managers Approve project development product documentation Contribute to regulatory authority inspections (ANSM, FDA, MHRA, etc.), partner audits or Ipsen Corporate audits as quality experts Support performance and continuous improvement of Quality activities and processes: Participate in the implementation and monitoring of performance indicators in his area of activity and propose improvement actions Support and contribute to continuous improvement projects within or outside the Quality Department by representing Pharm Dev Quality Assurance Contribute to the quality documentation evolution To be considered for this role, you will have a bachelor’s degree or equivalent in a scientific or technical discipline of relevance. At least 3-5 years’ direct experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, CMC development and/or Manufacturing Operations for Biologics products. Knowledge and experience of monoclonal antibody and/or antibody drug conjugate CMC development is desirable, as well as experience working with third party manufacturing contractors. If you feel that this could be the right next step for you, we would be delighted to engage with your application. LI-HYBRID IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.