Senior GCP Auditor

NantWorks, LLC

Job Overview

Location

Remote

Job Type

Full-time

Full Job Description

📋 Description

• The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols, playing a critical role in maintaining inspection readiness and supporting the development of life-saving immunotherapies.
• Day to day, the role involves maintaining and updating the Clinical Trial Quality Management system, contributing to SOP development and review, managing incident management programs, scheduling and conducting audits (vendor, internal, for-cause, and site audits), preparing audit documentation, validating findings, reviewing trial-related documents, applying regulatory requirements to clinical studies, supporting cross-functional GCP compliance issue resolution, leading training initiatives, tracking QA metrics, and assisting during regulatory inspections.
• The role sits within ImmunityBio’s Quality Assurance team, collaborating closely with Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing, and Data Management to uphold the highest standards in clinical trial execution for a commercial-stage biotechnology company developing next-generation cancer and infectious disease therapies.
• In this role, the individual will deepen expertise in GCP regulations (ICH E6 R2), lead audit programs, drive inspection readiness initiatives, influence cross-functional quality culture, and contribute directly to the integrity and success of clinical trials advancing ImmunityBio’s mission to harness the immune system to defeat cancer and infectious diseases.

🏖️ Benefits

• 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
• Discretionary bonus and equity award eligibility
• Annual base pay range: $140,000–$154,000 (National Market) or $145,500–$160,000 (Premium Market)

Skills & Technologies

GCP

Senior

Remote

Degree Required

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NantWorks, LLC

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About NantWorks, LLC

NantWorks is a diversified holding company founded by Dr. Patrick Soon-Shiong that invests in and operates businesses across biotechnology, healthcare data infrastructure, digital entertainment, and secure communications. Its portfolio includes initiatives in precision medicine, genomic sequencing, AI-driven clinical decision support, low-latency networking, and immersive media technologies. The company integrates advanced data analytics, cloud computing, and machine learning to accelerate biomedical research and deliver personalized therapies. Through subsidiaries and strategic partnerships, NantWorks seeks to create an integrated ecosystem linking patients, providers, researchers, and payers to improve outcomes and reduce healthcare costs while advancing innovation across its sectors.

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