QA Operations CGT Teamlead
Core
Lead and develop a team of QA professionals to support Cell & Gene Therapy (CGT) manufacturing operations, ensuring compliant release of therapies.
Role type
Senior IC QA Operations Team Lead
Builds
CGT manufacturing operations (batch records, deviations, CAPA, change controls)
Domain
Life Sciences / Biotechnology / Cell & Gene Therapy
Required skills
cGMP compliance, team leadership, root cause analysis, risk assessment, regulatory knowledge (FDA/EMA), quality documentation, performance metrics analysis
Preferred skills
Electronic quality management systems experience
Responsibilities
Lead and coach QA team, oversee daily QA activities (batch review, deviations, CAPA), ensure cGMP compliance, act as primary QA contact for manufacturing, lead quality investigations and audits, monitor quality performance metrics
Seniority
Senior, hands-on IC with leadership responsibilities
