Director, GxP Auditing

* 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 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.* 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.* 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 appropriateEveryone 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. #J-18808-Ljbffr

Created: 2025-09-21