Description
We're looking for a Clinical QA Manager, working in Pharmaceuticals and Medical Products industry in 155 Tice Boulevard, Woodcliff Lake, New Jersey, 07677, United States.
Job Responsibilities:
- Chairs the Regulatory Authority Facilitation Team, ensuring that company clinical facilities and clinical sites are prepared for clinical inspections and that the inspections are successfully facilitated.
- Writes Inspection Readiness Plans as necessary.
- Facilitates sponsor and site inspections as necessary.
- Manages the Clinical Document Audit function, planning, preparing, performing, and reporting on CQA audits of Clinical Study Reports and Trial Master Files.
- Develops Study Audit Plans and prepares, performs, and reports on CQA audits of investigator sites.
- Plans, prepares, performs, and reports on CQA audits of internal processes.
- Provides GCP and Lessons Learned training.
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