The Quality Manager will be supporting the activation of commercial gene therapy Authorised Treatment Centres (ATC)
The successful applicant will perform quality risk assessments and assist with completion of quality agreements, provide operational support for commercial site selection and activation of apheresis and cell-therapy laboratory centers.
Responsibilities
* Work closely with the Audit and Inspection quality function to establish the audit strategy for Auditing and Performance oversight to evaluate treatment centers ensuring compliance with standards established by applicable regulatory, licensing, and accrediting bodies
* Conduct treatment center Audits where required
* Actively engage with the Audit Management, Vender Management and Apheresis Infusion Operations functions on site qualifications
* Establish and maintain Quality Agreements