Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Quality Issue Lead - FSP in the United States.
This role sits at the center of clinical quality operations, ensuring that quality events are accurately identified, assessed, and investigated within strict regulatory timelines. You will act as a key driver of compliance and operational excellence across global clinical trial activities, helping ensure issues are properly escalated, documented, and resolved. Working within a highly regulated GCP/GxP environment, you will lead end-to-end quality event management, from triage through root cause analysis and CAPA oversight. The position requires strong analytical thinking, regulatory awareness, and the ability to collaborate across multidisciplinary clinical teams. You will also contribute to continuous improvement initiatives, enhancing case management processes and quality systems. This is a high-impact role where your work directly supports patient safety, data integrity, and inspection readiness across clinical development programs.
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Quality Issue Lead - FSP in the United States.
This role sits at the center of clinical quality operations, ensuring that quality events are accurately identified, assessed, and investigated within strict regulatory timelines. You will act as a key driver of compliance and operational excellence across global clinical trial activities, helping ensure issues are properly escalated, documented, and resolved. Working within a highly regulated GCP/GxP environment, you will lead end-to-end quality event management, from triage through root cause analysis and CAPA oversight. The position requires strong analytical thinking, regulatory awareness, and the ability to collaborate across multidisciplinary clinical teams. You will also contribute to continuous improvement initiatives, enhancing case management processes and quality systems. This is a high-impact role where your work directly supports patient safety, data integrity, and inspection readiness across clinical development programs.
