Clinical QA / GCP Manager
Edison-New Brunswick Metro Area, NJ
BS/MS in Life Sciences or related: 8 years in a R&D Clinical pharmaceutical or health care company with clinical operations experience Extensive knowledge and experience in ICH-GCP Process Control or ICH-GCP Quality Assurance systems
- Responsible to analyse, track, report and reinforce adherence to applicable performance measures.
- Leads the tracking and reporting of compliance to the established clinical trial processes.
- Oversees and recommends corrective actions based upon report outputs; ensures that training is developed and implemented as applicable to redirect teams to better
- 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.
- Process Expertise serves as subject matter expert and input into new SOPs on behalf of TMO, ensures compliance to and adequate training opportunities for new SOPs and Business Guidance. Serves as Lead SME on the monitoring processes as requested.
- Tracks deviations from Monitoring SOPs and ensures appropriate documentation is filed and corrective actions are taken
- Identifies procedural gaps and drives correction with process improvements where applicable.
- Conducts and supports conduct of vendor qualifications as needed; documents and files qualification evidence appropriately.
- 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.
- Leads the conduct of Trial Master File quality control checks.