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Quality Assurance Specialist

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Ipsen

Nov 11

  • Job
    Full-time
    Mid & Senior Level
  • Wrexham
  • Quick Apply

AI generated summary

  • You need a bachelor's degree in a relevant field, 3-5 years in regulatory Pharma QA/QC, and knowledge of biologics, monoclonal antibodies, and third-party manufacturing experience.
  • You will manage QA approvals, oversee quality deviations, ensure compliance, perform audits, and support continuous improvement in clinical product quality.

Requirements

  • 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.

Responsibilities

  • 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).
  • 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.
  • 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.
  • 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.

FAQs

What is the location of the Quality Assurance Specialist position?

The position is based at our Wrexham site.

Who will the Quality Assurance Specialist report to?

The Quality Assurance Specialist will report directly to the Product and Regulatory Quality Assurance Senior Manager based in France.

What are the main objectives of the Quality Assurance Specialist role?

The main objectives include QA approval of semi-finished and finished products for clinical trials, managing quality deviations, and maintaining quality relationships with contract development and manufacturing organizations (CDMOs).

What type of products will the Quality Assurance Specialist be working with?

The specialist will work with small molecules, toxins, medical devices, and Ipsen established products.

What are the key responsibilities of the role?

Key responsibilities include batch record review, managing quality activities with CDMOs, handling quality events such as deviations and change controls, and supporting development projects.

What qualifications are required for this position?

A bachelor’s degree or equivalent in a scientific or technical discipline is required, along with at least 3-5 years of direct experience in the regulated pharmaceutical industry, specifically in Quality Assurance and CMC development.

Is experience with monoclonal antibodies or antibody drug conjugates preferred?

Yes, knowledge and experience of monoclonal antibody and/or antibody drug conjugate CMC development is desirable.

Will the Quality Assurance Specialist be involved in regulatory inspections?

Yes, the specialist will contribute to regulatory authority inspections, partner audits, and Ipsen corporate audits as a quality expert.

What role does the Quality Assurance Specialist play in continuous improvement initiatives?

The specialist will participate in the implementation and monitoring of performance indicators and support continuous improvement projects within or outside the Quality Department.

What is the main focus of the Pharmaceutical Development Quality team?

The main focus is to actively contribute to the strategy of becoming a center of excellence in the development of biologics, neurotoxins, small molecules, and medical devices.

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Ipsen

Manufacturing & Electronics
Industry
5001-10,000
Employees

Mission & Purpose

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in 88 countries