CMO Quality Manager

Title:

CMO Quality Manager

Company:

Ipsen Biopharm Ltd

Job Description:

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.

The External Manufacturing network has become a critically important part of Ipsen’s specialty care business due to a number of recent strategic acquisitions where products are supplied from CMOs.

The CMO Quality Manager - External Manufacturing will lead the quality oversight of partners under its responsibility, provide quality leadership, technical quality expertise and guidance to internal cross-functional teams. In this role you will work in collaboration with others within the Quality department. You will be an expert in Quality Assurance with the gravitas and maturity of experience to work with our manufacturing partners, joint ventures, and our own manufacturing community. The role will also ensure that the highest standards of Quality Operations (QA & QC) are implemented and maintained at Contract Manufacturing Organisations (CMOs) and Contract Laboratories.

This is a permanent position reporting into the Quality Director – External Manufacturing, who is in France. This opening can be based in any one of the following Ipsen locations – London Paddington, Paris, Dublin, or Wrexham, UK.

The successful candidate will need to show the following Key Technical Competencies:

• QA and QC experience for products manufactured by CMOs including regional, national, and international audits

• Extensive experience of Internal & External Quality auditing, CAPA management deviation management & risk assessments

• Strong domestic and international regulatory inspections compliance background and detailed knowledge and application of cGMP, GDP, ICH regulations and international regulatory expectations.

• Knowledge of biotech and aseptic, synthetic small molecule and formulation processes with the ability to creatively problem solve

• Ability to influence external and internal stakeholders in a multicultural environment.

Experience & Qualifications:

Ideal: MSc in a Life Sciences discipline. 7 years hands-on experience gained in Quality Assurance in contract manufacturing environment. Experience in Drug Substance and control testing labs would be a plus.  Minimum: 5 years hands on experience on manufacturing site (Quality assurance, validation, production)

If you are looking for your next new opportunity within a fast-moving global, dynamic, and challenging environment with great opportunities, we would be delighted to engage with your application.

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Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.