Director, GxP Auditing

职位描述

We are seeking a Director for a GxP Auditing role. The Director of GxP Auditing will lead Kite’s global audit program, overseeing the strategic planning, execution, and continuous improvement of GxP audits across the organization. This role includes managing a team of auditors, providing mentorship, performance evaluations, and long-term career development. The Director ensures compliance with global regulatory requirements, marketing authorization holder expectations, and internal quality standards.

The Quality Leadership Team is open to considering applicants from other regions and for the role to be performed remotely.

• 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.

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