Quality Engineer III

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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.

Job Description

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

• • Bachelors 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
  • Masters 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: $107185.00 - $138710.00. 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:

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at 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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view the Know Your Rights poster.

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.

Required Experience:

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