Senior GCP Auditor

Role: GCP Auditor ensuring compliance with ICH, FDA, and company SOPs in clinical trials for immunotherapy and cell therapy programs, including the FDA-approved ANKTIVA. Responsibilities: conduct and coordinate vendor, site, and internal audits; develop and review quality documentation; monitor incident management; maintain inspection readiness; support regulatory inspections and cross-functional GCP compliance efforts. Requirements: Bachelor's in life sciences or engineering with 7+ years (or Master's with 4+ years) in GCP-biologics/pharmaceutical environment; CQA or similar certification preferred; experience with TMF or electronic documentation systems advantageous. HighValue: focus on biologics, immunotherapy, cell therapy, oncology (cancer vaccines, immunotherapies), clinical phases (preclinical, IND, Ph1-3); GCP compliance, audit management, inspection readiness, FDA interactions. WorkSetup: hybrid/onsite options in Southern California; 25-30% travel expected.