Overview

Director, GxP Auditing at Kite Pharma – lead Kite’s 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 Kite’s 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

• PhD with 8+ years of relevant experience in the pharmaceutical industry OR
• Master’s degree with 10+ years of relevant experience in the pharmaceutical industry OR
• Bachelor’s degree with 12+ years of experience in the pharmaceutical industry OR
• Associate’s degree with 14+ years of experience in the pharmaceutical industry OR
• High School Degree with 16+ years of experience in the pharmaceutical industry.

Preferred Qualifications

• 10+ years of relevant experience in the pharmaceutical industry and a BS or BA.
• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
• Prior people management experience.
• Experience with ATMPs, autologous manufacturing, and complex supply chains.
• Certification in auditing (e.g., ASQ, IRCA) or regulatory affairs.
• Familiarity with digital audit tools and data analytics platforms.
• Demonstrates in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Demonstrates substantial knowledge of industry best practices and trends.
• Is comfortable interacting with regulatory agencies as needed and possess the ability to represent Kite in public forums.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Able to travel up to 30% of the time
• Expert knowledge of GMPs and regulatory requirements and expectations
• Deep understanding of global GMP regulations, especially in cell and gene therapy environments.
• Proven experience managing global audit programs and leading cross-functional teams.
• Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
• History of being accountable for actions and driving results
• Good judgment and logical thought processes in collecting and synthesizing relevant data and information to make independent and timely decisions
• Ability to communicate, influence, and escalate issues and decisions, as appropriate

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 www.kitepharma.com.