Senior GCP Auditor
ImmunityBio, Inc.
August 29, 2026
Remote
United States
Clinical Research and Development
Position Summary
The Senior GCP Auditor ensures GCP compliance with ImmunityBio SOPs, ICH and US FDA regulations/guidelines, and clinical study protocols. Works cross-functionally with Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing, and Data Management to maintain GCP Quality Management System compliance and inspection readiness.
Essential Functions / Responsibilities
- Maintain and update the Clinical Trial Quality Management system.
- Contribute to development/review of SOPs and controlled documents.
- Ensure compliance with SOPs and ICH GCP E6 (R2).
- Manage incident management via complaints, deviations, and CAPAs.
- Schedule/plan/coordinate/conduct audits (vendor/supplier, internal, compliance visits, for-cause, and clinical trial sites).
- Prepare audit documentation (plans, reports, certificates, corrective action plans).
- Validate audit findings and follow-up to ensure satisfactory resolution; review final audit documents.
- Review trial documents (protocols/amendments, ICFs, pharmacy manuals, CSRs) and apply regulatory/study protocol requirements.
- Support resolution of GCP compliance issues and training efforts.
- Maintain QA tracking spreadsheets (deviations, CAPAs, complaints, audit findings/files).
- Lead inspection readiness efforts; assist during inspections/audits; represent QA in meetings.
Education & Experience (Required)
- Bachelor’s in life sciences/engineering + 7+ years in GCP-Biologics/Pharma; or Master’s + 4+ years.
Qualifications (Preferred)
- CQA or other audit certifications.
- TMF/electronic document management experience.
Skills
- Strong planning/prioritization; analytical/problem-solving; detail-oriented.
- Demonstrated ICH GCP E6 (R2) understanding.
- Proficient written/verbal communication; multi-project/multitask ability; timeline-focused and flexible.
Working Environment
- Remote; flexible hours; 25–30% travel.
Benefits (as stated)
- Medical, Dental, Vision; wellness programs; EAP; life/AD&D; STD/LTD; healthcare/dependent care FSAs; 401(k) match; 529; PTO (11 holidays; unlimited PTO for exempt); other listed perks.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled).
The Senior GCP Auditor ensures GCP compliance with ImmunityBio SOPs, ICH and US FDA regulations/guidelines, and clinical study protocols. Works cross-functionally with Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing, and Data Management to maintain GCP Quality Management System compliance and inspection readiness.
Essential Functions / Responsibilities
- Maintain and update the Clinical Trial Quality Management system.
- Contribute to development/review of SOPs and controlled documents.
- Ensure compliance with SOPs and ICH GCP E6 (R2).
- Manage incident management via complaints, deviations, and CAPAs.
- Schedule/plan/coordinate/conduct audits (vendor/supplier, internal, compliance visits, for-cause, and clinical trial sites).
- Prepare audit documentation (plans, reports, certificates, corrective action plans).
- Validate audit findings and follow-up to ensure satisfactory resolution; review final audit documents.
- Review trial documents (protocols/amendments, ICFs, pharmacy manuals, CSRs) and apply regulatory/study protocol requirements.
- Support resolution of GCP compliance issues and training efforts.
- Maintain QA tracking spreadsheets (deviations, CAPAs, complaints, audit findings/files).
- Lead inspection readiness efforts; assist during inspections/audits; represent QA in meetings.
Education & Experience (Required)
- Bachelor’s in life sciences/engineering + 7+ years in GCP-Biologics/Pharma; or Master’s + 4+ years.
Qualifications (Preferred)
- CQA or other audit certifications.
- TMF/electronic document management experience.
Skills
- Strong planning/prioritization; analytical/problem-solving; detail-oriented.
- Demonstrated ICH GCP E6 (R2) understanding.
- Proficient written/verbal communication; multi-project/multitask ability; timeline-focused and flexible.
Working Environment
- Remote; flexible hours; 25–30% travel.
Benefits (as stated)
- Medical, Dental, Vision; wellness programs; EAP; life/AD&D; STD/LTD; healthcare/dependent care FSAs; 401(k) match; 529; PTO (11 holidays; unlimited PTO for exempt); other listed perks.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled).