Senior GCP Auditor

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 functional teams in Clinical Trials which include Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to 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 that non‑compliance issues are addressed with satisfactory resolution. Review the final audit documents for accuracy. Review trial‑related documents (e.g., 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 of deviations, CAPAs, complaints, audit findings, and audit files as applicable. 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 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 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 systems 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 ability to be detail‑oriented, while managing multiple projects simultaneously. Demonstrated understanding and application of ICH GCP E6 (R2). Proficient in communication both verbal and written. Multitasks across multiple functional areas. Timeline focused and flexible in work scheduling to meet the demands of a multi‑product clinical phase pharmaceutical company. Working remotely with flexibility in working schedule, including off‑hours, second shift, weekends; 25%-30% travel may be required. Compensation National Market (all markets unless identified as Premium) $140,000 (entry‑level qualifications) to $154,000 (highly experienced) annually. Premium Market (Los Angeles, San Diego, San Francisco, New York City, Chicago & Boston) $145,500 (entry‑level qualifications) to $160,000 (highly experienced) annually. Benefits & Perks 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 and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes 11 Holidays Exempt Employees are eligible for Unlimited PTO Non‑Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day EEO & Anti‑Discrimination At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide 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 NantHealth Inc.