Director, GxP Auditing

Overview

Director, GxP Auditing at Kite Pharma lead Kites global audit program, overseeing the strategic planning, execution, and continuous improvement of GxP audits across the organization. Manage a team of auditors, provide mentorship, performance evaluations, and long-term career development. Ensure compliance with global regulatory requirements, marketing authorization holder expectations, and internal quality standards.

Responsibilities

• Manages QA personnel, including organizing and prioritizing group tasks, performing training, writing performance reviews and guiding personnel in longer-term development.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements, to facilitate compliance with regulatory agencies, customer and MA holder requirements.
• Develops, implements, and maintains systems, programs and processes to ensure compliance with Current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), along with compliance of protocols, GMPs and safety regulations.
• Responsibilities may include the approval of processes affecting all manufactured products into Europe and other countries.
• Creates, implements, and qualifies current and new programs, policies, processes, procedures and controls to ensure that performance and quality of products conform to established standards and agency guidelines.
• Reviews and approves training programs regarding implementation of quality systems. Interfaces with regulatory agencies as required, representing Kite to authorities and regulatory inspectorate bodies as required.
• Team Leadership & Development : Lead and develop a global team of auditors, fostering technical growth, collaboration, and a strong compliance mindset. Provide coaching and direction to ensure consistent execution and professional development.
• Global Audit Strategy : Define and execute a comprehensive audit strategy aligned with global regulatory expectations (FDA, EMA, MHRA, PMDA, PIC / S) and Kites quality objectives. Ensure risk-based coverage across internal operations, suppliers, and contract manufacturers.
• Audit Execution & Oversight : Oversee the planning, execution, and reporting of audits across all GMP subsystems, including Quality Systems, Production, Facilities & Equipment, Laboratory Controls, Materials, and Packaging & Labeling.
• Performance Metrics & Reporting : Establish and monitor audit KPIs, trends, and effectiveness metrics. Present insights and risk signals to senior leadership and quality councils to drive informed decision-making.
• Regulatory Readiness & Inspection Support : Lead audit readiness initiatives and support regulatory inspections, including post-inspection response and remediation planning.
• Continuous Improvement : Maintain and enhance audit procedures, tools, and templates in alignment with ICH Q10, 21 CFR Parts 210 / 211, and evolving industry standards.
• Cross-Functional Collaboration : Partner with Legal, HR, Regulatory, and Commercial teams to ensure compliance across business functions, including review of promotional materials and ethical conduct training.
• Training & Awareness : Deliver training and guidance on compliance topics, fostering a culture of integrity and regulatory awareness across the organization.

Basic Qualifications

Preferred Qualifications

Salary range for this position is $191,250.00 - $247,500.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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 medical, dental, vision, and life insurance plans. Eligible employees may participate in benefit plans, subject to plan terms.

For more information about Kite, please visit .

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