CSP Oversight Specialist II
Core
Ensuring clinical service providers (CSPs) are qualified, assessed, and compliant with GCP and company policies to support Iovance's TIL therapy development.
Role type
Senior IC Clinical Quality Assurance Specialist (CSP Oversight)
Builds
Qualified and compliant service provider network for cell therapy clinical trials
Domain
Biotechnology / Cell Therapy / Clinical Research
Required skills
GCP compliance, risk-based assessment, quality event management, CAPA management, quality agreement negotiation, regulatory guideline knowledge, organizational skills, critical thinking
Preferred skills
None stated
Technologies
MS Office
Responsibilities
Maintain CSP qualification/requalification programs, assess/mitigate CSP risks, manage quality events and non-compliances, negotiate quality agreements, represent at study management meetings
Seniority
Mid-Senior, hands-on IC