Manager, IT Quality Engineering; LIMS - El Segundo, CA or Fredericksburg, VA

Position: Manager, IT Quality Engineering (LIMS) - El Segundo, CA or Fredericksburg, VA
We are seeking an experienced IT professional with a strong background in Lab Vantage 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.
* 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
* 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 Lab Vantage LIMS
* 5+ years of experience with SQL
* 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 Lab Vantage 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

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.
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