Snr Director, Quality CGT Personalized Medicine
Core
Strategic Quality leadership for personalized medicine and advanced cell therapies (CGT) across the patient journey, ensuring compliance, governance, and continuous improvement.
Role type
Senior Director, Quality Systems (Strategy & Organizational Leadership)
Builds
Enterprise Quality Systems for CGT programs from development through commercial lifecycle
Domain
Biotechnology / Cell and Gene Therapy / Regulated Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic Quality Systems leadership, Risk management, GxP compliance oversight, Cross-functional matrix leadership, Organizational development, Data integrity, Change control management, CAPA management, Management review board execution, Executive presence
Preferred skills
Master's degree in business analytics or management life sciences
Technologies
Artificial intelligence, Digital reporting solutions
Responsibilities
Define and execute CGT Quality Systems across clinical, launch, and commercial stages; Lead and mentor team members to build organizational capability; Provide end-to-end compliance oversight for internal and external quality operations; Lead Quality oversight across the end-to-end patient treatment journey; Partner with stakeholders to develop advanced digital reporting solutions and AI use in CGT; Improve compliance and strengthen proactive quality management processes
Seniority
Senior, hands-on IC with strategic leadership
