Senior GCP Auditor

🕒 May 4

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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 entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. • Interact 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. • Maintain inspection readiness at all times. • Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices. • Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions). • Ensures 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, a written audit report 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.

🎯 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

🏖️ 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