ImmunityBio, Inc. · 1 day ago
Senior GCP Auditor
California, United States
Full-time
Hybrid
Mid, Senior Level
$121K/yr - $133K/yr
4+ years expImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing cell and immunotherapy products to enhance the immune system's ability to combat cancer. The Senior GCP Auditor is responsible for ensuring GCP compliance with various regulations and guidelines, maintaining inspection readiness, and interacting with cross-functional teams to uphold quality standards in clinical trials.
Health CareHealth DiagnosticsTherapeutics
Responsibilities
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
Manages the incident management program through monitoring of complaints, deviations and CAPAs
Schedules, plans, coordinates, and conducts vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits
Prepares required documentation to support audit activities including audit plans, audit reports, audit certificates and corrective action plans
Validates accuracy of audit findings, a written audit report and follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution
Reviews 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
Assists senior staff during regulatory inspections or other audits
Represents QA department at internal and external meetings supporting clinical programs
Performs other Quality related duties, as assigned
Qualification
Required
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
We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
Company
ImmunityBio, Inc.
ImmunityBio, Inc.
501-1000 employees
H1B Sponsorship
ImmunityBio, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (4)
2023 (6)
2022 (7)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.36BKey Investors
Oberland CapitalNantCapitalPatrick Soon-Shiong
2025-07-25Post Ipo Equity· $80M
2025-04-08Post Ipo Equity· $75M
2024-12-11Post Ipo Equity· $100M
Leadership Team
Enrique Diloné
Chief Technology Officer
Leonard Sender
COO
Recent News
Los Angeles Business Journal
2025-12-24
Company data provided by crunchbase