Director, Head of Compliance
Core
Director of Quality Compliance leading site compliance programs, audits, and health authority inspections for a CAR T cell therapy manufacturing facility.
Role type
Senior IC Director, Quality Compliance
Builds
Inspection-ready manufacturing sites and robust compliance programs for CAR T cell therapy
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, Biologics experience, Six Sigma, operational excellence
Technologies
QMS, BPDR, FDA/EMA/Health Canada/PMDA regulatory frameworks
Responsibilities
Oversee end-to-end site preparation and management of corporate audits and regulatory inspections; Lead Fact Finding meetings for significant events; Manage NTMs, BPDRs, Product Defect Notifications, and Drug Shortage Notifications; 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 aligned with strategic quality objectives.
Seniority
Director, strategic leadership & execution