Quality (QA) Lead - CDMO
Core
Lead Quality Assurance to secure MHRA Manufacturing and Import Authorisation (MIA) license for the world's first automated CDMO for Regenerative Medicine.
Role type
Senior Quality Assurance Lead (Regenerative Medicine/CDMO)
Builds
Automated cell manufacturing sites for stem-cell derived therapies (Parkinson's, vision loss, bone repair)
Domain
Regenerative Medicine / Biologics / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP QA experience, MHRA/EU GMP compliance, PQS management, audit leadership, regulatory licensing strategy
Preferred skills
ATMP/Cell Therapy release experience, eQMS implementation, FDA regulations knowledge
Technologies
MasterControl, electronic Batch Records, Manufacturing execution systems
Responsibilities
Lead MHRA MIA(IMP) license acquisition, establish and maintain PQS, ensure production compliance, lead audits, plan quality strategy, prepare for commercial batch release
Seniority
Senior, hands-on IC
