Job Description
The Manager of Global Quality Management - Good Clinical Practice (GQM - GCP) reports directly to the Associate Director of GQM-GCP and is considered to be a position of increased responsibility within the function.
The candidate will be responsible for managing and conducting Good Clinical Practice (GCP) audits for clinical trials including clinical investigator sites, internal systems, Trial Master Files (TMFs), Clinical Study Reports (CSRs) and processes and may support external service provider audits. Responsibilities include managing timeliness of audit reporting and corrective and preventive actions (CAPAs) review to resolution, supporting escalation, investigation and resolution of Quality Issues / Events and potential GCP serious breaches, GQM-GCP quality engagement member of a Study Team and/or Otsuka and Global Quality initiatives, performing risk assessments of clinical trials and ensuring process enhancement of GQM-GCP audit tools, procedures and processes. the candidate will manage and support GCP inspection readiness activities within their assigned study teams and may be involved in GCP regulatory authority inspections. The candidate should also be open to additional training as deemed applicable (i.e. GVP, Document Management etc.).
Key Responsibilities:
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