Clinical QA Process Manager
Edison-New Brunswick Metro Area, NJ
- A minimum of 8 years in a Clinical QA Role pharmaceutical or health care company, desirable clinical operations experience
- Extensive knowledge and experience in ICH-GCP Process Control or ICH-GCP Quality Assurance systems and Health Authority regulations
- Demonstrated ability for leading initiatives with cross-functional teams and implementation of recommendations Experience working in matrix environment and in global teams
- Process Compliance Ensures CAPA commitments are adequate, submitted and completed in a timely manner.
- Ensures audits and inspections are supported, tracked and outcomes requiring corrective action are managed.
- Reviews CAPAs and makes appropriate recommendations to keep consistent actions across TMO.
- Initiates and documents root cause investigations of critical issues in collaboration with Quality Assurance and Clinical Operations. Supports the generation and dissemination of Tactical Memos and Lessons Learned communication in collaboration with monitoring training.
- Leads the conduct of Trial Master File quality control checks. Ensures TMO compliance with required training by tracking and reporting compliance status for the Global, Regional and Country level organizations.
- Metrics and Quality KPI Leads the tracking and reporting of compliance to the established clinical trial processes. Responsible to analyse, track, report and reinforce adherence to applicable performance measures. Oversees and recommends corrective actions based upon report outputs; ensures that training is developed and implemented as applicable to redirect teams to better Quality KPI scores. Tracks audit and inspection findings, report on results, track trends, generate lessons learned. Ensures effective ongoing operations of the Risk Mitigation Assessment process to improve the rate of compliance of countries to TMO quality standards.