Senior GCP Auditor

November 16

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ImmunityBio, Inc.

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Biotechnology • Healthcare Insurance • Pharmaceuticals

ImmunityBio, Inc. is a biotechnology company focused on developing innovative immunotherapies to enhance the immune system's ability to fight cancer and infectious diseases. By harnessing the power of the body’s immune response, ImmunityBio aims to provide breakthrough treatments that can improve patient outcomes and longevity in challenging diseases.

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• Ensure GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols • Interact cross-functionally with functional teams in Clinical Trials including Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to the GCP Quality Management System and all applicable regulatory requirements • 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 • 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 audits (vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits) • Prepare required documentation to support audit activities • Validate accuracy of audit findings and ensure satisfactory resolution of non-compliance issues • Review trial related documents e.g. protocols, protocol amendments, ICFs, pharmacy manuals and CSRs • Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance • Support training on company procedures, GCP regulations, and documentation systems • Maintain QA department spreadsheets tracking deviations, CAPAs, complaints, audit findings, and audit files

🎯 Requirements

• 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 • 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 their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company.

🏖️ 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