Description:
The Manager, CQA chairs the Regulatory Authority Facilitation Team (RAFT) responsible for ensuring that companies clinical facility in WCL is prepared for a health authority inspection, and that clinical sites are prepared per an inspection readiness plan.
RAFT also ensures that sponsor and site inspections are appropriately facilitated by CQA.
This position also manages the CQA Clinical Document Audit function which is responsible for managing (and conducting) audits of Clinical Study Reports, and also conducts audits of Trial Master Files.
This position will also audit clinical investigational sites, perform inspection readiness visits at sites, develop both audit plans and inspection readiness plans, and provide GCP/Lessons Learned training as needed. In addition, this position will conduct audits of internal processes.
All of these activities are essential to obtaining marketing approvals of regulatory submissions.
Responsibilities:
1.Chair the Regulatory Authority Facilitation Team, and ensure that companies clinical facility in WCL and clinical sites are prepared for clinical inspections and the inspections are successfully facilitated. Write Inspection Readiness Plans as necessary. Facilitate sponsor and site inspections as necessary.
2. Manage the Clinical Document Audit function, and plan, prepare, perform, and report on CQA audits of Clinical Study Reports and Trial Master Files
3. Develop Study Audit Plans and prepare, perform, and report on CQA audits of investigator sites
4. Plan, prepare, perform, and report on CQA audits of internal processes
5. Provide GCP and Lessons Learned training
Job Qualifications
- BS or MS degree in relevant field.
- 4-7 years of experience in Clinical Quality Assurance methods and processes in industry setting strongly preferred. Related experience (for example, several years of clinical research study monitoring with knowledge of CQA processes) will be considered in lieu of direct CQA experience.
- Ability to travel 30% of the time.