The successful candidate will ensure that their cell and gene therapy products are manufactured and released according to quality guidelines, regulatory requirements and trial needs. You will also be involved in the set-up and validation of the manufacturing processes. As QP you provide guidance and direction to Development, Production and Quality staff regarding compliance with quality standards and procedures.
Suitable candidates will need to possess skills/experience in the following areas: -
- M.Sc. or PhD degree in biotechnology, biology or equivalent
- Advanced therapy, ATMP, or stem cell experience is essential
- Experience working in a GMP regulated environment
- Strong QA experience – Document control, Deviation & CAPA management, Change control
- You will either be a Qualified Person or be studying to become a QP.