Accreate has been retained by a leading US based cell therapy company to open operations in Ireland. This individual will report directly to the Global QA Head and be responsible for assuring consistent quality of production by developing and enforcing Current Good Manufacturing Practice (CGMP) systems to meet the requirements of US and EU regulations and guidelines. The incumbent will be responsible for the QP oversight and release of commercial and clinical products as required by the Regulations. They will be responsible for interacting with the QA Operations, QA Compliance and QA GLP / GCP Leads ensure robust Quality Systems are established and maintained and are compliant with EU Regulations and directives.
If you have experience in oversight at EU level and working directly with US leadership teams within a biologics organisation, please do get in touch to discuss further.