Senior Manager, CGP Compliance & Issue Management (Hybrid)

Job description

Job Description GENERAL POSITION SUMMARY: The Senior Manager, RDQ Compliance is responsible for leading quality assurance and compliance activities in support of Compliance and Issues Management. This role requires expertise in overseeing investigations, root cause analysis, CAPA development, and effectiveness checks, as well as the ability to educate and guide stakeholders in performing effective root cause investigations. The ideal candidate will have experience in linking issues and risks, conducting data analysis, performing spot checks, and leveraging data trending to identify patterns and drive continuous improvement. This individual will work closely with Quality Leads, Study Team members, and other stakeholders while exemplifying Vertex Core Values. RESPONSIBILITIES: Quality Oversight and Monitoring: - Conduct regular spot checks to ensure adherence to GCP (Good Clinical Practice) standards and compliance with established processes. - Perform data trending and analysis to identify recurring issues, emerging risks, and opportunities for process improvement. - Monitor and evaluate key performance indicators (KPIs) to assess the effectiveness of quality and compliance activiti...