Senior GCP Auditor

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial‑stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease. Why ImmunityBio? Developing cutting‑edge technology to transform the lives of patients with cancer and to develop next‑generation therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases. Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. Collaboration across different areas of the company. Professional development opportunities in a growing company. Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This position interacts cross‑functionally with clinical trials teams, including Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management, to ensure compliance with the GCP Quality Management System and all applicable regulatory requirements. This role is responsible for maintaining inspection readiness at all times. Essential Functions Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices. Contribute to the development and review of SOPs and other controlled documents (forms, templates, work instructions). Ensure compliance with SOPs and ICH GCP E6 (R2) standards. Manage the incident management program through monitoring of complaints, deviations and CAPAs. Schedule, plan, coordinate, and conduct vendor/supplier audits, internal audits, compliance visits, for‑cause audits, and clinical trial site audits. Prepare required documentation to support audit activities including audit plans, audit reports, audit certificates and corrective action plans. Validate accuracy of audit findings, written audit reports, and follow‑up activities to assure non‑compliance issues are addressed with satisfactory resolution. Review final audit documents for accuracy. Review trial related documents such as protocols, protocol amendments, ICFs, pharmacy manuals and CSRs. Apply regulations, guidance document requirements, and study protocol requirements to clinical trial studies. Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. Support joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards. Maintain all associated QA department spreadsheets tracking deviations, CAPAs, complaints, audit findings, and audit files. Lead development and implementation efforts for inspection readiness at all times. Assist senior staff during regulatory inspections or other audits. Represent QA department at internal and external meetings supporting clinical programs. Perform other quality‑related duties as assigned. Education & Experience Bachelor’s Degree in a life sciences or engineering discipline with a minimum of seven (7) years of experience in a GCP‑Biologics or Pharmaceutical environment, or Master’s degree in a life sciences or engineering discipline with a minimum of four (4) years of experience in a GCP‑Biologics or Pharmaceutical environment. CQA or other audit certifications are a plus. Prior TMF or electronic document management system experience is a plus. Knowledge, Skills, & Abilities Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines. Strong problem‑solving and analytical skills with demonstrated detail orientation while managing multiple projects simultaneously. Demonstrated understanding and application of ICH GCP E6 (R2). Proficient in verbal and written communication. Ability to multitask across multiple functional areas. Timeline focused and flexible in work scheduling to meet the demands of a multi‑product clinical phase pharmaceutical company. Working Environment / Physical Environment This position works remote. Flexibility in working schedule, i.e., off‑hours, second shift, weekends. 25%–30% travel may be required. Salaries and Benefits This position is eligible for a discretionary bonus and equity award. The annual base pay range depends on qualifications, prior experience, and geographic location. National Market (all markets unless identified as Premium): $140,000 to $154,000 annually. Premium Market (Los Angeles, San Diego, San Francisco, New York City, Chicago, Boston): $145,500 to $160,000 annually. Benefits include medical, dental and vision plan options, health and financial wellness programs, employer assistance program (EAP), company‑paid and voluntary life/AD&D, short‑term and long‑term disability, healthcare and dependent care flexible spending accounts, 401(k) retirement plan with company match, 529 education savings program, voluntary legal services, identity theft protection, pet insurance, employee discounts, rewards and perks, paid time off (PTO) including 11 holidays, unlimited PTO for exempt employees, and 10 vacation days, 56 hours of health pay, 2 personal days and 1 cultural day for non‑exempt employees. We are committed to providing tools and resources to optimize health and wellness. Equal Opportunity Statement At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy provides equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law. #J-18808-Ljbffr