Director, Commercial QCA
ImmunityBio, Inc.
June 26, 2026
On-site
Culver City, CA
Operations
Position Summary
The Director, Commercial QCA is responsible for the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, and compliance (cGMPs and internal standards) for the commercial N-803 program and other QCA programs advancing to commercial stage.
Essential Functions
- Ensure compliant, efficient Quality Control Analytical operations by overseeing in-house and outsourced in-process testing, lot release, and stability.
- Transfer, review, and approve methods and documentation (product specifications; protocols/SOPs; testing reporting; analytical method development/validation; stability studies).
- Own and oversee assay trending programs.
- Design and implement methods and strategies to increase efficiency and improve knowledge of safety, purity, efficacy, potency, and stability; transfer methods into QCA groups.
- Ensure QCA decisions align with Quality System, GMP, and regulatory requirements.
- Provide budgets for current/future operations, including lab relocations and new lab implementation.
- Develop and mentor Analytical Quality Control staff; oversee performance (interviewing/hiring/training; planning/assigning work; performance appraisal; rewards/discipline; addressing complaints; resolving problems).
- Perform ad-hoc and cross-functional duties/projects as assigned.
Education & Experience
- BS in biology/chemistry or related field + 15 years quality experience with 8+ years management required; or MS + 10 years with 8+ years management; or PhD + 8 years with 8+ years management.
- Extensive experience with assay qualification/validation/transfer (required).
- FDA PLI/surveillance/inspection experience with acceptable outcome (required).
- Start-up pharmaceutical company experience (preferred).
Knowledge, Skills, & Abilities (Required/Preferred)
- Thorough biologics manufacturing knowledge (cell culture, purification, analytical characterization); cell therapy desirable.
- Proven QC leadership; driving quality initiatives; managing regulatory inspections.
- Strong organization, attention to detail, prioritization; excellent communication.
- In-depth analytical method development/validation and statistical quality control.
- In-depth GMP/SOPs/pharmaceutical regulations; sound scientific judgment; ability to interpret/enforce regulatory requirements.
- Ability to work with contractors/suppliers to ensure compliance.
Working Environment / Physical Environment
- On-site; flexible schedule as needed (off-hours/second shift/weekends); lab work as needed; ability to gown PPE.
Benefits / Pay / Application Instructions
- Discretionary bonus and equity award.
- Annual base pay range: $215,000–$236,500.
- Application window: expected to close 60 days from posting or sooner if filled/closed.
The Director, Commercial QCA is responsible for the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, and compliance (cGMPs and internal standards) for the commercial N-803 program and other QCA programs advancing to commercial stage.
Essential Functions
- Ensure compliant, efficient Quality Control Analytical operations by overseeing in-house and outsourced in-process testing, lot release, and stability.
- Transfer, review, and approve methods and documentation (product specifications; protocols/SOPs; testing reporting; analytical method development/validation; stability studies).
- Own and oversee assay trending programs.
- Design and implement methods and strategies to increase efficiency and improve knowledge of safety, purity, efficacy, potency, and stability; transfer methods into QCA groups.
- Ensure QCA decisions align with Quality System, GMP, and regulatory requirements.
- Provide budgets for current/future operations, including lab relocations and new lab implementation.
- Develop and mentor Analytical Quality Control staff; oversee performance (interviewing/hiring/training; planning/assigning work; performance appraisal; rewards/discipline; addressing complaints; resolving problems).
- Perform ad-hoc and cross-functional duties/projects as assigned.
Education & Experience
- BS in biology/chemistry or related field + 15 years quality experience with 8+ years management required; or MS + 10 years with 8+ years management; or PhD + 8 years with 8+ years management.
- Extensive experience with assay qualification/validation/transfer (required).
- FDA PLI/surveillance/inspection experience with acceptable outcome (required).
- Start-up pharmaceutical company experience (preferred).
Knowledge, Skills, & Abilities (Required/Preferred)
- Thorough biologics manufacturing knowledge (cell culture, purification, analytical characterization); cell therapy desirable.
- Proven QC leadership; driving quality initiatives; managing regulatory inspections.
- Strong organization, attention to detail, prioritization; excellent communication.
- In-depth analytical method development/validation and statistical quality control.
- In-depth GMP/SOPs/pharmaceutical regulations; sound scientific judgment; ability to interpret/enforce regulatory requirements.
- Ability to work with contractors/suppliers to ensure compliance.
Working Environment / Physical Environment
- On-site; flexible schedule as needed (off-hours/second shift/weekends); lab work as needed; ability to gown PPE.
Benefits / Pay / Application Instructions
- Discretionary bonus and equity award.
- Annual base pay range: $215,000–$236,500.
- Application window: expected to close 60 days from posting or sooner if filled/closed.