Senior Specialist, Quality Risk Management
ImmunityBio, Inc.
June 27, 2026
On-site
El Segundo, CA
Operations
Position Summary
The Senior Specialist, Quality Risk Management is responsible for supporting all aspects governing Quality Risk Management for ImmunityBio. This position interacts cross-functionally across the organization.
Essential Functions
- Supports implementation of the Quality Risk Management (QRM) program through procedures, work instructions, and training materials.
- Delivers QRM training and coaching.
- Tracks QRM program records and deliverables.
- Participates in electronic system validation projects and related documentation/testing as needed.
- Prepares/presents QRM metrics data, reports, and meeting minutes; provides and may execute remediation.
- Partners with stakeholders to embed risk-based approaches in daily operations and initiatives.
- Provides guidance on risk mitigation for deviations, CAPAs, change controls, and investigations.
- Leads/facilitates risk assessments.
- Leads continuous improvement initiatives related to QRM.
- Serves as QRM Subject Matter Expert during audits/inspections.
- Maintains Quality Systems and Quality Documentation Records.
- Cross-trains on Quality & Regulatory Compliance and Supplier Quality programs.
Education & Experience (Required/Preferred)
- BS in life sciences or engineering; 7+ years in GMP-regulated biologics/pharma.
- 5+ years in clinical/commercial regulations (21 CFR 210/211, 1271, 810, 2001/83/EC, ISO, ICH, PIC/S).
- Risk tools experience (FMEA, FTA, HACCP, HAZOP, risk ranking, statistical tools).
- Regulatory inspection prep experience (direct inspector interaction preferred).
- Clinical/commercial phase experience preferred; CQE or Six Sigma Green/Black Belt preferred.
Working/Skills
- Strong written communication; critical review/authorship and corrective action partnering.
- Interfaces with senior leaders; works independently and in teams.
- Microsoft Office (Excel, Word, OneNote, PowerPoint, Visio, SharePoint) and Adobe Professional.
- Onsite; flexible schedule; travel up to 10%.
Benefits (as stated)
- Medical, dental, and vision; wellness programs; EAP; life/AD&D; short/long-term disability; FSA; 401(k) match; 529; PTO; etc.
Application instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
The Senior Specialist, Quality Risk Management is responsible for supporting all aspects governing Quality Risk Management for ImmunityBio. This position interacts cross-functionally across the organization.
Essential Functions
- Supports implementation of the Quality Risk Management (QRM) program through procedures, work instructions, and training materials.
- Delivers QRM training and coaching.
- Tracks QRM program records and deliverables.
- Participates in electronic system validation projects and related documentation/testing as needed.
- Prepares/presents QRM metrics data, reports, and meeting minutes; provides and may execute remediation.
- Partners with stakeholders to embed risk-based approaches in daily operations and initiatives.
- Provides guidance on risk mitigation for deviations, CAPAs, change controls, and investigations.
- Leads/facilitates risk assessments.
- Leads continuous improvement initiatives related to QRM.
- Serves as QRM Subject Matter Expert during audits/inspections.
- Maintains Quality Systems and Quality Documentation Records.
- Cross-trains on Quality & Regulatory Compliance and Supplier Quality programs.
Education & Experience (Required/Preferred)
- BS in life sciences or engineering; 7+ years in GMP-regulated biologics/pharma.
- 5+ years in clinical/commercial regulations (21 CFR 210/211, 1271, 810, 2001/83/EC, ISO, ICH, PIC/S).
- Risk tools experience (FMEA, FTA, HACCP, HAZOP, risk ranking, statistical tools).
- Regulatory inspection prep experience (direct inspector interaction preferred).
- Clinical/commercial phase experience preferred; CQE or Six Sigma Green/Black Belt preferred.
Working/Skills
- Strong written communication; critical review/authorship and corrective action partnering.
- Interfaces with senior leaders; works independently and in teams.
- Microsoft Office (Excel, Word, OneNote, PowerPoint, Visio, SharePoint) and Adobe Professional.
- Onsite; flexible schedule; travel up to 10%.
Benefits (as stated)
- Medical, dental, and vision; wellness programs; EAP; life/AD&D; short/long-term disability; FSA; 401(k) match; 529; PTO; etc.
Application instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).