Director, Quality
Core
Strategic leadership of Quality Assurance and Quality Control functions to ensure regulatory compliance and batch disposition in a commercial cell therapy manufacturing facility.
Role type
Director, Quality (Manufacturing)
Builds
Commercial-scale autologous and allogeneic cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing compliance & batch disposition)
Required skills
Quality Management System (QMS) leadership, cGMP/ICH/regulatory compliance, team leadership, audit/inspection management, batch disposition, supplier oversight, project management
Preferred skills
Sterile drug product manufacturing, drug substance manufacturing, cell therapy experience, manufacturing site operations leadership, start-up environment experience
Technologies
None explicitly listed (focus on regulatory frameworks and systems)
Responsibilities
Lead the site Quality function and QMS, develop quality strategy and staffing plans, oversee QA/QC teams, manage audits and remediation, serve as primary contact for customers and regulatory agencies, review and approve batch records and materials, manage departmental budget
Seniority
Director, strategic leadership & team management
