Senior GCP Auditor

Role: Senior GCP Auditor ensuring compliance with ICH, FDA, and internal SOPs across clinical trials in a biopharma setting. Objectives include maintaining inspection readiness and supporting quality assurance for immunotherapy and cell therapy programs, including FDA-approved therapies like ANKTIVA. Responsibilities: conduct and coordinate vendor, internal, and site audits; develop and review GCP documentation; monitor complaint and deviation management; assist in regulatory inspections; and support training on GCP standards. Requirements: Bachelor's in life sciences or engineering with 7+ years (or Master's with 4+ years) experience in GCP-biologics/pharma; CQA or related certification preferred; experience with TMF or electronic document systems advantageous. Skills: strong organizational, analytical, and communication skills; proficient in GCP E6 (R2); capable of managing multiple projects and prioritizing deadlines. High-Value: focus on immunotherapy or biologics development, GCP compliance, audit management, and regulatory inspection support in a clinical phase environment. Work setup: onsite or remote with 25-30% travel; flexible hours may be required.