Director Product Quality Leader
Core
Lead end-to-end product quality strategy and lifecycle management for autologous, allogeneic, and in-vivo cell therapy products from clinical stage through commercialization.
Role type
Director, Product Quality Leader (Cell & Gene Therapy)
Builds
Advanced therapeutic modalities including drug substance, drug product, viral delivery systems (LVV, AAV), and gene-edited cell therapy products
Domain
Biopharmaceuticals / Cell & Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (quality specifications, control strategies, regulatory filings)
Required skills
cGMP regulations expertise, analytical method validation, process development, tech transfer, viral vector expertise, comparability strategy design, stability program management, CTD section authoring, risk register management, cross-functional stakeholder influence
Preferred skills
MS/PhD in Life Sciences or Engineering, leadership in CGT or Biologics
Technologies
LVV, AAV, CMC systems, regulatory filing platforms
Responsibilities
Lead the Product Quality Team (PQT) sub-team, develop and implement overall Product Quality Strategy, own and maintain lot release and stability specifications, support design and execution of analytical comparability studies, oversee annual product reviews for commercial products, author and review CMC sections for global filings (INDs, BLAs, MAAs), act as SME during health authority inspections, review and evaluate major process changes for product safety and efficacy
Seniority
Director, strategic leadership & cross-functional influence