GCP Operational Quality Senior Manager
Core
Senior manager overseeing quality assurance and compliance for clinical trial operations, ensuring adherence to GCP guidelines and protecting subject safety and data integrity.
Role type
Senior IC clinical quality manager
Builds
Clinical trial programs for drugs, biologics, and devices
Domain
Biotechnology / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
ICH GCP R2 knowledge, global regulatory compliance (FDA, EU, MHRA), risk-based audit planning, CAPA management, root cause analysis, inspection readiness, KPI trend analysis, vendor quality management
Preferred skills
Experience with drugs, biologics, and devices, process improvement initiatives, Microsoft Office proficiency
Technologies
Microsoft Office (Word, Excel, PowerPoint, Visio)
Responsibilities
Develop and execute study-level audit plans; lead domestic and international audits for clinical investigators; manage quality issue investigations and CAPA development; liaise with CROs and investigator sites; provide inspection support for regulatory agencies; review protocols and participate in Operational Review Boards.
Seniority
Senior, hands-on IC
