Senior GCP Auditor

🔥 23 hours ago

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ImmunityBio, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

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.

📋 Description

• Ensure GCP compliance with ImmunityBio standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols • Interact cross-functionally with teams in Clinical Trials • Maintain and update the Clinical Trial Quality Management system • Contribute to the development and review of SOPs and other controlled documents • Manage the incident management program • Schedule and conduct vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits • Prepare documentation for audit activities • Validate accuracy of audit findings and follow-up activities • Review trial related documents and apply regulations to clinical trial studies • Participate in solving GCP compliance issues • Support training on company procedures and GCP regulations • Maintain QA department spreadsheets

🎯 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

🏖️ 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