Scope of Responsibilities
The position will support Clinical Quality Assurance program to ensure clinical trials are conducted in accordance with relevant regulations, guidelines, procedures and protocols. The incumbent is also responsible for conducting GCP compliance audits of global investigator sites, vendors, clinical study reports and internal systems/processes, assisting in inspection readiness program and GCP related process improvement.
- Supports development of GCP-related quality system SOPs in compliance with applicable regulatory requirements and best industry practice.
- Conducts Good Clinical Practice compliance audits of investigator sites, clinical vendors, trial master files, and internal processes.
- Reviews and approves corrective/preventive actions to reported audit observations and ensures proper follow-up activities are completed and documented.
- Tracks and archives audit-related documentation.
- Provides QA advice based on analysis and interpretation of updates to GCP regulations to assure best Clinical/QA practices.
- Conducts training to internal clinical departments or investigators/site staff, as needed.
- Assists with inspection readiness efforts.
- 25 - 35% travel required.
6+ years in the Biotech/Pharmaceutical Industry with 3+ years of clinical quality assurance auditing experience.
- B.S./M.S. in a relevant science field.
- Demonstrated GCP audit conduct experience is required.
- Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
- Excellent verbal and written communication skills, with the ability to work well in teams or independently and able to prioritize work, manage multiple projects while maintaining quality.
- Ability to deal with ambiguity leading to creative and pragmatic solutions to GCP compliance risk areas.
- Experience supporting regulatory authority inspections is desired.
- Chinese speaking/writing skills preferred.
- RQAP-GCP certification is a plus