General Summary:

The Sr. Manager of Clinical Quality will be responsible for building out and managing quality management infrastructure for the clinical development organization. The role will be responsible for leading process development, managing department training matrices, owning the CAPA and deviation process, coordinating contracted audits and driving inspection readiness activities.

Job Duties and Responsibilities: 

• Provide oversight and management of the clinical quality management system including driving clinical process development and improvement, managing periodic review of department SOPs and department training matrices.
• Implement and manage the clinical process deviation and corrective and preventive action (CAPA) process.
• Implement periodic quality reviews with department leadership.
• Coordinate clinical QA audits including investigative site audits and service provider qualification audits.
• Maintain listing of audits conducted, obtain timely and adequate audit finding responses, scheduled requalification audits as appropriate.
• Maintain clinical quality related records (qualified service provider list, audit related documents).
• Oversee inspection readiness activities (set up of inspection hosting logistics, facilitating mock inspections, implementation of inspection related communication plans with external parties, driving storyboarding activities etc) and host / assist in hosting health authority GCP related inspections.