New · posted Nov 8
Gilead Sciences · Biotechnology
QA Specialist III
- El Segundo, CA
- On-site
- Full-time
- Senior & Principal
The role
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations. Join Kite and help create more tomorrows.
What you need
3 ways to qualify
Master’s
+ 3+ years of experience
Master’s Degree with 3+ years of relevant GMP or regulated industry experience, including auditing experience; or
- or
Bachelor’s
+ 5+ years of experience
Bachelor’s Degree with 5+ years of relevant GMP or regulated industry experience, including auditing experience; or
- or
High school
+ 8+ years of experience
High School Diploma with 8+ years of relevant GMP or regulated industry experience, including auditing experience.
Basic Requirements
Knowledge
- Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
- Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
- Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates strong verbal, technical writing and interpersonal skills.
- Demonstrates proficiency in Microsoft Office applications
Preferred Qualificationsnice to have
- Provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and /or novelty.
- Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
- To provide QA oversight and approval of CAPA and EV records that havemoderate to significant levels of complexity and /or novelty.
- Ensure CAPAs are initiated and resolved in a timely manner.• Ensure escalation of deviations per procedures
- Identify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant manner
- Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.
- Additional duties as assigned.
- These duties can be delegated to designated deputies of a satisfactory qualification level as needed
The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Pay
$107,185 – $138,710 a year
Employer providedFor additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Where you'll work
El Segundo, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in El Segundo, CAWorking conditions
For Current Kite Pharma Employees and Contractors
Please apply via the Internal Career Opportunities portal in Workday.
Equal opportunity, accessibility and legal noticesGilead Sciences's statements, word for word
For jobs in the United States
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California20 roles publishing pay
Senior & Principal roles in the US65 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $107,185 | — | $138,710 |
| California (middle half) | $109,750 | $138,500 | $156,625 |
| All US (middle half) | $92,500 | $117,000 | $152,000 |
This role: Gilead Sciences's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 345 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Gilead's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA7
- Documentation and SOPs6
- GMP and compliance5
- Quality systems and risk2
- Collaboration and leadership2
- Lab testing and methods1
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studiesNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
Company hiring pulse
Gilead on Regulatory Jobs
- 90
- Open roles
- 90
- Distinct roles
- 8
- Locations
By discipline
- Quality52 53%
- Clinical30 30%
- Regulatory17 17%
By level
- Director55 56%
- Manager18 18%
- Senior & Principal14 14%
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QA Specialist III at Gilead
Open until filled. $107K–$139K a year, employer provided.