Director, Analytical Product Quality
Core
Overseeing quality assurance for analytical development, method validation, and stability programs in Cell & Gene therapy product lifecycle.
Role type
Director, Analytical Product Quality
Builds
Cell & Gene therapy products
Domain
Biotechnology / Regulated Pharmaceuticals / Cell & Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory knowledge (FDA/EMA), GXP lifecycle expertise, method development for cellular programs, root cause analysis, risk management, operational excellence (LEAN/Six Sigma), quality system strategy
Preferred skills
None stated
Technologies
None stated
Responsibilities
Maintain QA oversight of method development and qualification; Lead quality review for analytical validation protocols and reports; Drive investigations for out-of-specifications and implement corrective actions; Support development of analytical strategy with cross-functional stakeholders; Lead quality oversight of reference standard programs; Participate in developing global Quality system standards and SOPs; Review and approve regulatory submissions and deviation investigations; Identify compliance risks and implement mitigating controls; Manage contract test lab quality agreements.
Seniority
Director, strategic oversight & cross-functional leadership
