Sr Quality Engineer I

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 areseekinga highly motivated individual to join us as Sr. QualityEngineer Iat ourEl Segundolocation. 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 todeterminewhich 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 approachmethodology 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 validationfor 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:

• Masters degree and 4 years of relevant computer systems validation experience in a cGMPenvironment

OR

• Bachelors 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 cGMP 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.