Director, Head of Compliance
Core
Director of Quality Compliance responsible for developing, implementing, and maintaining high standards of quality compliance at a CAR T cell therapy manufacturing facility.
Role type
Senior IC Quality Compliance Director
Builds
Inspection-ready manufacturing sites and robust quality compliance programs
Domain
Biopharmaceuticals / Cell Therapy / Manufacturing
Required skills
Strategic thinking, project management, risk management, audit leadership, regulatory inspection management, team leadership, cross-functional partnership, data integrity oversight, quality risk management
Preferred skills
CAR T experience, Six Sigma, operational excellence
Technologies
QMS, BPDRs, Product Defect Notifications
Responsibilities
Oversee end-to-end site preparation and management of corporate audits and regulatory inspections; Lead fact-finding meetings for significant events; Manage notifications (NTMs, BPDRs, etc.); Identify and trend quality and compliance risk signals; Develop and oversee execution of site internal audit program; Lead site Quality Risk Management and Data Integrity programs; Own the Site Compliance Plan; Develop departmental goals, budgets, and succession plans.
Seniority
Director, strategic leadership & execution