Walker Cole International is currently supporting a rapidly growing biotechnology organisation focused on advanced therapy medicinal products (ATMPs) to identify a Senior QA Specialist on a 12-month fixed-term contract.
This is an opportunity to join a clinical-stage business at the forefront of cell and gene therapy, where you will take ownership of quality oversight across outsourced manufacturing and contribute to the development of quality systems.
Key responsibilities for the Senior QA Specialist include:
*Performing batch review and supporting QP certification activities
*Managing deviations, CAPAs, and change controls in line with GMP
*Providing QA oversight of external manufacturing partners (CDMOs)
*Supporting the development and improvement of PQS processes and documentation
The successful Senior QA Specialist will have:
*Experience in GMP Quality Assurance within pharmaceuticals or biotechnology
*Knowledge of sterile manufacturing, biologics, or ATMPs
*Experience managing core QA processes (deviations, CAPAs, batch review)
*Strong understanding of EU/UK GMP and ability to make risk-based decisions
GMP | QA | ATMP | Cell & Gene Therapy | Biologics | Sterile | Batch Review | QP | Deviations | CAPA | Change Control | PQS | QRM | eQMS | CDMO | Vendor Management | Audits | Clinical | EU GMP | ICH