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Senior Director, Quality IT

United States - California - Santa MonicaInformation TechnologyRegular

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. Would you like to join us in this mission?

We are seeking a highly motivated individual to join us as a Senior Director, Quality IT for the Kite Information Technology group.

The Senior Director, Quality IT will be accountable for liaising with the Kite Quality Leadership Team and Tech Ops Business Operations and key stakeholders in order to solve organizational information technology problems by helping develop business-enabling technology solutions that support Kite’s Quality and Business Operations organization’s business capabilities and needs.  This role provides business process development, solution development, and project oversight and accountability.   This role will also lead all Quality systems such as LIMS, ELN, QMS, and various QC site equipment.  This will be a critical role within the Kite IT reporting to the Head of Global Technical Operations IT.  It is a highly cross functional role working closely with the senior leadership team from various business groups dealing with GxP Systems.

Responsibilities of the Senior Director, Quality IT include, but are not limited to:

  • Act as the key IT point of contact for both the Quality and Business Operations organization including being part of the organization’s leadership team
  • Oversee the long-term planning, including 3-5 year strategic roadmap and implementation of key technology solutions to support Quality and Business Operations business capabilities
  • Work closely with the Quality and Business Operations business leadership team, sponsors, and other key stakeholders to understand their technology requirements and identify/implement “best fit” technology solutions to meet their needs
  • Operational ownership of various Quality systems in an FDA regulated biotech or pharmaceutical environment
  • Accountable for the IT metrics as part of the Quality quarterly metric reporting
  • Bring best practices to deliver solutions for the business problems through experience driven vision, planning, and hands on experience within a regulated GxP environment
  • Accountable for the prioritization and execution of new systems and/or enhancements to existing systems; Support day to day operations of various Quality systems like LIMS, QMS, ELN, QC site equipment, etc.
  • Responsible for the prioritization and execution of new systems and/or enhancements to existing systems of various Business Operations systems and tools
  • Enforce IT Governance and Change Control amongst IT and business teams to prioritize and implement improvements for all Quality and Business Operations systems
  • Collaborate closely with other IT groups (infrastructure, service desk, IT security, and portfolio management) on the overall IT solutions delivery process, infrastructure, and database requirements
  • Assist in evaluating vendor solutions, develop alternatives, and recommend technical solutions in meeting the evolving needs of the quality and production development group
  • Lead and manage quality system implementations from requirement management through testing and validation
  • Collaborate with Quality team on computerized system validation (CSV) activities like IQ/OQ/PQ and other regulatory requirements to ensure the compliant and validated state of all Quality systems
  • Responsible for the tools, automated testing, and resources to support CSV activities
  • Accountable for system administration and integration of Quality systems with other enterprise and technical operations systems
  • Assist in developing, modifying, and reviewing SOPs, work instructions, and other relevant documentation for quality systems administration
  • Manage internal and external teams to implement, deploy, and manage GxP systems
  • Identify and lead the implementation of analytics solutions for quality groups to deliver KPIs related to Quality data and process monitoring

Basic Qualifications:

  • PhD and 12+ years of industry experience OR
  • MS/MA and 12+ years of industry experience OR
  • BS/BA and 14+ years of industry experience OR
  • High School diploma and 18+ years of industry experience

Preferred Qualifications:

  • BS in Life Sciences, Engineering, or Computer Science; Masters preferred  
  • 12+ years’ experience working within a GxP regulated setting (Laboratory, Quality, Manufacturing, IT)
  • Knowledge of cGMP/ICH/FDA regulations with 21 CFR Part11; GAMP knowledge
  • 10+ years of experience in implementing systems for Quality and integrating them with other enterprise and technical operations systems
  • Experience with various lab instruments used with product development and manufacturing and integrating them with other systems
  • Experience in implementing and supporting quality systems like LIMS, QMS, QC equipment; any experience with Labvantage LIMS, Oracle Agile QMS, Veeva QMS, ComplianceWire, and Veeva Quality Document system will be a plus
  • Experience with Manufacturing Execution System, Electronic Batch Records systems, and integration with LIMS will be a plus
  • Experience with SAP ERP system and integration with LIMS will be a plus
  • Experience with Clarity will be a plus
  • Experience in defining the requirements for data warehouse with data from various quality, product development, and manufacturing systems
  • Experience in handling infrastructure and instruments qualifications and validations for regulatory requirements
  • Experience with emerging cloud, SaaS, and web technologies
  • Ability to handle conflicting priorities from various business groups and prioritize them based on the business requirements and resource availability
  • Experience in implementing and leading change management and governance process, owning deviations and change control in a regulated environment
  • Effective organization and time management skills, with the ability to work under pressure and adhere to project deadlines in a fast-paced environment
  • Strong written & verbal communication and presentation skills with good executive presence to interact with senior leadership team from various business groups
  • Proficient in tools like PowerPoint, Visio, and other tools to develop process flows and presentations
  • Experience in leading, managing, and mentoring a team of Quality systems professionals