Quality Oversight Specialist
il y a 2 semaines
Ipsen Biopharm Ltd is a biopharmaceutical company dedicated to improving the quality of life of patients through the development of innovative medicines in oncology, neuroscience, and rare diseases.
The External Manufacturing network has become a critical component of Ipsen's specialty care business due to recent strategic acquisitions where products are supplied from Contract Manufacturing Organizations (CMOs).
The CMO Quality Assurance Manager will lead the quality oversight of partners under their responsibility, providing 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, ensuring the highest standards of Quality Operations (QA & QC) are implemented and maintained at Contract Manufacturing Organizations (CMOs) and Contract Laboratories.
This is a permanent position reporting into the Quality Director – External Manufacturing, who is based 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 demonstrate 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, and 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).
We are seeking a highly skilled and experienced Quality Assurance professional to join our team at Ipsen Biopharm Ltd.
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