Quality Engineer III

1110 Kite Pharma, Inc.; Oceanside (CA); On-site; USD 107,000 - 139,000; Full time

Benefits offered by this job

Health insurance

Competitive compensation

Job summary

Kite Pharma is seeking a Quality Engineer III in California to act as a subject matter expert in CSV, CQV, Data Integrity, and Quality Risk Management. The role provides independent quality review of qualification, validation, and compliance activities to ensure systems, facilities, equipment, and processes meet regulatory and company requirements.

The position partners with cross-functional teams to evaluate quality impacts, manage compliance risks, and drive continuous improvement across the

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, Quality, or related field with 5+ years in Quality/Validation/Compliance in a regulated environment; or Master's with 3+ years.
• Experience supporting CSV, CQV, Quality Systems, or Data Integrity programs in a regulated environment.

Responsibilities

• Provide quality oversight for CSV, CQV activities.
• Maintain Data Integrity and Quality Risk Management programs for compliance.
• Review validation and risk assessment docs including protocols and reports.
• Lead risk assessments and investigations related to quality events and CAPAs.
• Support internal audits, regulatory inspections, and inspection readiness.

Skills

CSV knowledge

CQV

Data Integrity

Quality risk management

GxP understanding

Education

Bachelor's degree in Engineering or Life Sciences

5+ years in Quality/Validation/Compliance

Tools

CSA experience

Job description

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 fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

The Quality Engineer III serves as a subject matter expert in Computer System Validation (CSV), and Commissioning, Qualification, and Validation (CQV), Data Integrity, and Quality Risk Management.

This role provides independent Quality review and oversight of qualification, validation, and compliance activities to ensure systems, facilities, equipment, and processes meet applicable regulatory and company requirements.

The position partners with cross-functional teams to evaluate quality impacts, manage compliance risks, support inspection readiness, and drive continuous improvement.

Applying sound technical judgment and risk-based quality principles, the Quality Engineer III helps strengthen the Quality Management System (QMS) and supports consistent, compliant, and reliable operations.

The role also supports QMS activities, including change controls, risk assessments, investigations, internal and regulatory audits, and compliance assessments to maintain regulatory compliance and inspection readiness.

Key Responsibilities

• Provide quality oversight for Computer System Validation (CSV), Commissioning, Qualification, and Validation (CQV) activities.
• Maintain site Data Integrity and Quality Risk Management programs to ensure compliance with regulatory and company requirements.
• Review and approve validation, qualification, and risk assessment documentation, including protocols, reports, and technical assessments.
• Perform quality impact assessments and technical evaluations for change controls, deviations, investigations, and CAPAs.
• Partner with cross-functional teams to ensure systems, equipment, and processes are qualified and maintained in compliance with applicable regulations and internal procedures.
• Support internal audits, regulatory inspections, and compliance readiness activities.
• Analyze quality data and metrics to identify trends, support decision making, and drive continuous improvement initiatives.
• Lead or support risk assessments related to systems, facilities, materials, and manufacturing processes.
• Conduct gap assessments and compliance reviews to identify and remediate regulatory or procedural risks.
• Provide technical guidance and support for validation, data integrity, and quality compliance activities across the site.
• Review technical, validation, and quality records to ensure accuracy, completeness, and regulatory compliance.
• Participate in projects and initiatives that strengthen quality systems, compliance programs, and operational excellence.
• Additional duties as assigned.

Basic Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, Quality, or a related technical discipline with 5+ years of experience in Quality, Validation, Compliance, Manufacturing, or a regulated pharmaceutical/biotechnology environment; OR Master's degree in a related field with 3+ years of relevant experience.
• Computer Software Assurance (CSA) Experience supporting Computer System Validation (CSV), Commissioning, Qualification and Validation (CQV), Quality Systems, or Data Integrity programs in a regulated environment.
• Working knowledge of GxP, FDA, EU GMP, 21 CFR Part 11, Annex 11, and Data Integrity principles.
• Experience with quality processes including change controls, deviations, CAPAs, investigations, risk assessments, and audit support is a plus.
• Ability to review and interpret technical documentation, validation deliverables, and quality records for compliance with regulatory and company requirements.
• Strong verbal and written communication skills with the ability to effectively collaborate across Quality, Manufacturing, Engineering, Validation, and Information Technology functions.

Preferred Qualifications

• Experience in the biopharmaceutical, biotechnology, cell therapy, gene therapy, or pharmaceutical manufacturing industry.
• Experience supporting regulatory inspections, internal audits, and compliance initiatives.
• Familiarity with validation lifecycle activities for computerized systems, manufacturing equipment, and laboratory systems.
• Knowledge of quality risk management methodologies.
• Ability to develop and evolve complex quality concepts, standards, and methodologies based on sound quality engineering principles.
• Experience with electronic quality management systems (eQMS) and document management systems.

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*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable 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.

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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 [e-mail] 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. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.