Upvote
Downvote
Director, Clinical, Preclinical, And Diagnostic Quality Assurance
Share Job
- Suggest Revision
Full-time
- The Director, Clinical, Preclinical, and Diagnostic Quality Assurance ensures GLP, GCP, CAP/CLIA compliance with ImmunityBio Standard Operating Procedures (SOPs), ICH guidelines and US FDA regulations, and Preclinical and Clinical study protocols/plans.
- The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements.
- Oversees the Quality Management System (QMS) for all functional areas (preclinical [including bioanalytical], clinical and diagnostic) to be current with industry standards, guidance and best practices
- Subject matter expert in electronic document control systems, i.e., Veeva Vault, etc.
- Applies regulations which include but are not limited to GCP, GLP, 21 CFR Part 58 and 21 CFR Part 11, guidance document requirements, and study plan/protocol requirements to Preclinical and Clinical trial studies
Active Job
Updated 5 months agoSimilar Job
Relevance
Active