Senior GCP Auditor
ImmunityBio, Inc.
August 07, 2026
Remote
United States
Operations
Position Summary
- Ensure GCP compliance with company SOPs, ICH and US FDA regulations/guidelines, and clinical study protocols.
- Work cross-functionally with Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing, and Data Management.
- Maintain inspection readiness at all times.
Essential Functions
- Maintain/update the Clinical Trial Quality Management system aligned with industry standards, guidance, and best practices.
- Contribute to development/review of SOPs and controlled documents (forms, templates, work instructions).
- Ensure compliance with SOPs and ICH GCP E6 (R2) standards.
- Manage incident management via monitoring complaints, deviations, and CAPAs.
- Schedule/plan/coordinate/conduct vendor/supplier audits, internal audits, compliance visits, for-cause audits, and clinical trial site audits.
- Prepare audit documentation (plans, reports, certificates, corrective action plans); validate audit findings and follow-up resolution; review final audit documents.
- Review trial documents (protocols/amendments, ICFs, pharmacy manuals, CSRs) and apply regulations/study protocol requirements.
- Participate in resolving GCP compliance issues; support training on procedures, GCP regulations, and documentation systems.
- Maintain QA tracking spreadsheets (deviations, CAPAs, complaints, audit findings/files).
- Lead inspection-readiness implementation; assist senior staff during inspections/audits; represent QA at meetings.
Education & Experience
- Bachelor’s in life sciences or engineering with 7+ years in GCP-biologics/pharma; or Master’s with 4+ years.
- CQA or other audit certification (plus).
- TMF/electronic document management experience (plus).
Skills
- Plan/organize and prioritize to meet deadlines.
- Strong problem-solving/analytical, detail-oriented; manage multiple projects.
- Knowledge of ICH GCP E6 (R2); verbal/written communication.
- Ability to multitask across functional areas; timeline-focused and flexible.
Working Environment
- Remote; off-hours/weekends flexibility; 25–30% travel.
Benefits (if eligible)
- Medical, dental, and vision plan options; 401(k) match; Paid Time Off (11 holidays; exempt unlimited PTO; non-exempt vacation/health pay/personal/cultural days); EAP; life/AD&D; short/long-term disability; flexible spending accounts; wellness programs; other listed programs/perks.
Application Instructions
- Not specified.
- Ensure GCP compliance with company SOPs, ICH and US FDA regulations/guidelines, and clinical study protocols.
- Work cross-functionally with Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing, and Data Management.
- Maintain inspection readiness at all times.
Essential Functions
- Maintain/update the Clinical Trial Quality Management system aligned with industry standards, guidance, and best practices.
- Contribute to development/review of SOPs and controlled documents (forms, templates, work instructions).
- Ensure compliance with SOPs and ICH GCP E6 (R2) standards.
- Manage incident management via monitoring complaints, deviations, and CAPAs.
- Schedule/plan/coordinate/conduct vendor/supplier audits, internal audits, compliance visits, for-cause audits, and clinical trial site audits.
- Prepare audit documentation (plans, reports, certificates, corrective action plans); validate audit findings and follow-up resolution; review final audit documents.
- Review trial documents (protocols/amendments, ICFs, pharmacy manuals, CSRs) and apply regulations/study protocol requirements.
- Participate in resolving GCP compliance issues; support training on procedures, GCP regulations, and documentation systems.
- Maintain QA tracking spreadsheets (deviations, CAPAs, complaints, audit findings/files).
- Lead inspection-readiness implementation; assist senior staff during inspections/audits; represent QA at meetings.
Education & Experience
- Bachelor’s in life sciences or engineering with 7+ years in GCP-biologics/pharma; or Master’s with 4+ years.
- CQA or other audit certification (plus).
- TMF/electronic document management experience (plus).
Skills
- Plan/organize and prioritize to meet deadlines.
- Strong problem-solving/analytical, detail-oriented; manage multiple projects.
- Knowledge of ICH GCP E6 (R2); verbal/written communication.
- Ability to multitask across functional areas; timeline-focused and flexible.
Working Environment
- Remote; off-hours/weekends flexibility; 25–30% travel.
Benefits (if eligible)
- Medical, dental, and vision plan options; 401(k) match; Paid Time Off (11 holidays; exempt unlimited PTO; non-exempt vacation/health pay/personal/cultural days); EAP; life/AD&D; short/long-term disability; flexible spending accounts; wellness programs; other listed programs/perks.
Application Instructions
- Not specified.