Archived listing. The details below describe a past opening.
Onsite - Hybrid Eligible
United States - California - El Segundo
Full time
R0054175
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.
Job Description
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in this mission!
Sr. Quality Engineer I
We are seeking a highly motivated individual to join us as Sr. Quality Engineer I at our El Segundo location. The ideal candidate will build strong partnerships across the site and network organizations and thrive in an environment that values teamwork, change agility, risk-based decision making, and flexibility. This role is expected to make a significant contribution to a multi-disciplinary team and requires strong written and verbal communication skills, sound quality judgment, and a high degree of personal ownership.
The Sr. Quality Engineer I provides Quality Engineering oversight of site processes related to validated computer systems, including Computer System Configuration Management and Computer System Validation (CSV), ensuring compliance with regulatory requirements, lifecycle procedures, and Data Integrity expectations. This position supports and leads CSV activities at the El Segundo location, reviews and approves validation documentation and risk assessments, works with project teams to determine which elements require validation, and conducts impact assessments for proposed changes to computerized systems.
This role is expected to apply a quality-first mindset and make sound, risk-based decisions supported by clear quality and compliance rationale. The position ensures compliance with Kite procedures and all applicable regulatory requirements.
Responsibilities:
- Provide Quality Engineering oversight for validated computer systems, ensuring compliance with cGMP, applicable regulatory requirements, lifecycle procedures, Data Integrity expectations, and intended use requirements.
- Lead and support enterprise, cross-functional, and local computer system validation activities by providing validation approach,methodology, deliverables, and quality oversight.
- Review and approve validation lifecycle documentation, including Validation Plans, UAT plans, requirements and specifications, SOPs, test cases, protocols, Traceability Matrices, and Validation Summary Reports, in partnership with functional teams to ensure compliance and quality standards are met.
- Independently assessvalidationlifecycle deliverables, change records, and supporting documentation for accuracy, completeness, internal consistency, and readiness for approval.
- Evaluate proposed changes tovalidatedcomputer systems and recommend theappropriate levelof validationrequiredfor proposed changes.
- Provide quality oversight for change control activities related to validated computer systems, ensuring technical and quality impact assessments are performed in a compliantmannerand systemsremainin a validated state.
- Support risk-based validation of enterprise and site computer systems.
- Identify, pressure-test, and clearly communicate compliance, technical, and process risks early, escalating as needed to supporttimelydecision making and effective risk mitigation.
- Participate as the quality engineering representative in project team activities and computer system design discussions to ensure cGMP compliance and cross-site consistency.
- Clearly articulate quality rationale, validation expectations, and risk-based recommendations to cross-functional stakeholders.
- Support CSV projects across manufacturing and laboratory systems, including operational change management activities associated with those systems and applications.
- Support implementation and deployment of manufacturing automation systems, including integration with enterprise and supporting systems.
- Support new computer system introduction by serving as a technical resource and providing validation and quality expertise.
- Apply critical thinking and sound quality judgment when evaluating ambiguous, complex, or non-routine situations.
- Drive actions and commitments through closure with proactive communication of status, risks, and support needs.
- Drive continuous improvement and innovation in computer system validation and related quality processes.
- Support regulatory inspections and audits.
- Communicate effectively at all levels within Quality and cross-functional across departments and sites.
- Perform other duties as assigned.
Basic Qualifications:
- Master’s degree and 4+ years of relevant computer systems validation experience in a cGMPenvironment
OR
- Bachelor’s degree and 6+ years of relevant computer systems validation experience in a cGMP environment
OR
- Associate degree and 8+ years of relevant computer systems validation experience in a cGMP environment
OR
- High school diploma / GED and 10+ years of relevant computer systems validation experience in a cGMP environment
Preferred Qualifications:
- 6+ years of experience in an FDA-regulated environment with a strong understanding of cG M P requirements and risk-based validation principles.
- 6+ years of experience in software quality assurance and/or computer system validation.
- Strong working knowledge of cGMP, 21 CFR Part 11, Annex 11, Data Integrity, andvalidationlifecycle requirements.
- Proven ability to review qualification protocols and associatedvalidationlifecycle documentation, including identification and resolution of non-conformances and deviations.
- Demonstrated ability to apply critical thinking and problem-solving skills in complex or ambiguous situations.
- Ability to make sound, risk-based decisions and clearly document or explain the supporting quality rationale.
- Strong senseof ownership and accountability for deliverables, approvals, and follow-through.
- Ability to communicate proactively and effectively when facing challenges, competing priorities, or uncertainty.
- Excellent interpersonal, verbal, and written communication skills in a collaborative cross-functional environment.
- Proficiencywith Microsoft Office applications.
- Comfortable operating in a fast-paced and evolving environment.
The salary range for this position is: $123,930.00 - $160,380.00. 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
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.
Change The World With Us
Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.
While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.