Computer Jobs in Oceanside, CA

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

• 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; ORMaster'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:

* 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.