Associate Director, Clinical Study Quality Lead (Hybrid)
Core
Advanced quality assurance oversight of clinical trial operations and vendors across study phases to ensure GCP compliance and data integrity.
Role type
Senior IC clinical study quality lead (associate director level)
Builds
Clinical trials for drugs and biologics
Domain
Biotechnology / Clinical Development
Required skills
ICH-GCP guidelines, global regulations (FDA/EMA/MHRA), clinical trial phases (drugs/biologics), event management, root cause analysis, CAPA development, quality risk management, audit planning, inspection preparedness, KPI/metrics analysis, medical terminology, disease states
Preferred skills
Medical device manufacture experience, Cell and Gene Therapy transition, professional clinical trial certification (CCRP/RQAP-GCP)
Technologies
Microsoft Office (Word, Excel, PowerPoint, Smartsheet, Visio)
Responsibilities
Develop and execute audit/quality plans; oversee investigation and approval of quality event investigations and CAPAs; conduct directed or for-cause audits and site inspection preparations; partner with operational teams on risk-based quality plans; represent Quality in study management and compliance forums; mentor junior SQLs
Seniority
Senior, hands-on IC with potential line management responsibilities