Manager, IT Quality Engineering (lims) - El Segundo

Manager – Lims Cell Therapy It

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 Summary

We are seeking an experienced IT professional with a strong background in LabVantage LIMS and Quality Control processes. The successful candidate will have both technical capabilities and an ability to influence and manage people. An understanding of Artificial Intelligence (AI), Machine Learning (ML) and IT infrastructure is also beneficial. Previous experience working in a Good Manufacturing Practice (GMP) environment is a must.

This role will be responsible for working with Kite Quality Control to define requirements for their LIMS system with the goal of moving towards a paperless lab, work with other IT groups to ensure uninterrupted system uptime, and take on responsibilities of System Owner for the LIMS system (i.e., incident management, roadmap development/management). This role will collaborate with Gilead IT and vendors to ensure the reliability, performance and security of IT infrastructure hosting Kite's LIMS application.

Job Responsibilities

• Work with the business (Kite Quality) in defining and implementing LIMS technical solutions that support the ever-evolving needs of Kite
• Collaborate with Gilead IT Incident Command team to provide Level 2 support for incidents that can potentially interrupt Kite operations
• Assess, document, and deploy system patches in a controlled way that does not adversely impact business operations
• Successfully manage IT projects in collaboration with cross-functional teams
• Provide support for a Global Enterprise system (US-West Coast > US-East Coast > Europe)
• Work closely with Kite Quality Assurance, Quality Control, Stability, Gilead IT, and other teams
• Create, revise, and approve LIMS system SOPs and reports per GMP, FDA, EU, Global, and ICH guidelines
• Triage and evaluate site change requests, assess global impact, and prioritize accordingly
• Assist sites in identifying master data elements for LIMS deployment
• Ensure LIMS processes meet data integrity and GMP standards; promote global process adoption

Basic Qualifications

• 6+ years with BS/BA OR 4+ years with MS/MA required
• 5+ years of experience in a GMP regulated environment
• 5+ years of experience in LabVantage LIMS
• 5+ years of experience with SQL

Preferred Qualifications

• Strong understanding of FDA, ISO 13485, Medical Device Directive
• Prior experience managing a team
• Expertise in quality management systems and regulatory compliance
• Advanced computer skills and familiarity with quality management software
• Experience leading high-stakes engagements with tight coordination and rapid decision-making, ideally involving AI
• Deep knowledge of LabVantage processes such as sample management, batch release, stability, and lab execution
• Strong understanding of server, network and cloud technologies
• Experience with scripting and automation tools
• Understanding of security best practices and relevant regulations

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.

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.

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.