Value Stream Quality Manager
ImmunityBio, Inc.
June 26, 2026
On-site
El Segundo, CA
Operations
Position Summary
The Value Stream Quality Manager oversees the product lifecycle of ImmunityBio products from a quality perspective, supporting GMP production activities internally and at external CMOs. Ensures products meet established quality standards and regulatory/organizational expectations from new product introduction through commercialization.
Essential Functions
- Deploy Lean and Six Sigma tools to manage value stream flow.
- Manage end-to-end product lifecycle compliance with global GMP requirements.
- Own/lead quality programs for Value Stream Quality activities.
- Drive continuous improvement to enhance quality management and lifecycle oversight.
- Lead strategic quality planning for new product introduction, lifecycle phase transitions, and major change controls.
- Provide oversight for risk assessments, deviations, and CAPAs; conduct product impact assessments and review/approve relevant deviations.
- Review/approve product specifications and product protocols/reports for internal and external programs.
- Collaborate with internal/external partners to meet needs compliantly.
- Oversee investigations with robust root cause identification and corrective/preventive actions.
- Build CMO Quality/Manufacturing relationships; hold partners accountable.
- Support site audits/act as Quality Person-In-Plant (as assigned); support regulatory inspections as SME.
- Maintain assigned training; create/revise SOPs and controlled documents.
Education & Experience (Required)
- Bachelor’s degree in engineering/biological science/chemistry or related.
- 7+ years in clinical and/or commercial pharmaceutical/biopharmaceutical industry.
- 5+ years in Quality Assurance/Quality Control.
- Advanced experience with quality management systems across the product lifecycle (early through commercial).
- CMO experience.
Preferred
- Experience supporting FDA/EMA/MHRA inspections.
- Lean Six Sigma Greenbelt (certification preferred).
Skills/Knowledge (Required/Preferred)
- Biologics cGMP knowledge (recombinant protein and cell therapy); aseptic manufacturing knowledge required.
- Strong regulatory knowledge; clear technical writing and critical review skills.
- Problem-solving/analytical decision-making; effective communication and cross-functional interface.
- Proficient in Microsoft Office and Adobe Professional.
Benefits
- Medical, Dental, and Vision Plan Options.
- 401(k) Retirement Plan with Company Match; PTO includes 11 holidays; Exempt: Unlimited PTO; Non-Exempt: 10 vacation days, etc.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled).
The Value Stream Quality Manager oversees the product lifecycle of ImmunityBio products from a quality perspective, supporting GMP production activities internally and at external CMOs. Ensures products meet established quality standards and regulatory/organizational expectations from new product introduction through commercialization.
Essential Functions
- Deploy Lean and Six Sigma tools to manage value stream flow.
- Manage end-to-end product lifecycle compliance with global GMP requirements.
- Own/lead quality programs for Value Stream Quality activities.
- Drive continuous improvement to enhance quality management and lifecycle oversight.
- Lead strategic quality planning for new product introduction, lifecycle phase transitions, and major change controls.
- Provide oversight for risk assessments, deviations, and CAPAs; conduct product impact assessments and review/approve relevant deviations.
- Review/approve product specifications and product protocols/reports for internal and external programs.
- Collaborate with internal/external partners to meet needs compliantly.
- Oversee investigations with robust root cause identification and corrective/preventive actions.
- Build CMO Quality/Manufacturing relationships; hold partners accountable.
- Support site audits/act as Quality Person-In-Plant (as assigned); support regulatory inspections as SME.
- Maintain assigned training; create/revise SOPs and controlled documents.
Education & Experience (Required)
- Bachelor’s degree in engineering/biological science/chemistry or related.
- 7+ years in clinical and/or commercial pharmaceutical/biopharmaceutical industry.
- 5+ years in Quality Assurance/Quality Control.
- Advanced experience with quality management systems across the product lifecycle (early through commercial).
- CMO experience.
Preferred
- Experience supporting FDA/EMA/MHRA inspections.
- Lean Six Sigma Greenbelt (certification preferred).
Skills/Knowledge (Required/Preferred)
- Biologics cGMP knowledge (recombinant protein and cell therapy); aseptic manufacturing knowledge required.
- Strong regulatory knowledge; clear technical writing and critical review skills.
- Problem-solving/analytical decision-making; effective communication and cross-functional interface.
- Proficient in Microsoft Office and Adobe Professional.
Benefits
- Medical, Dental, and Vision Plan Options.
- 401(k) Retirement Plan with Company Match; PTO includes 11 holidays; Exempt: Unlimited PTO; Non-Exempt: 10 vacation days, etc.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled).