Director, Quality Compliance

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Key responsibilities of this job:

·      Lead, coach, and develop the Quality Compliance team, ensuring clear priorities, effective decision-making, and consistent execution of compliance activities across the site.

·       Ensure the site remains compliant with applicable regulatory requirements, marketing authorization holder expectations, customer commitments, and internal quality standards.

·       Maintain a high level of inspection readiness by developing and implementing a proactive strategy that supports successful regulatory inspections across all relevant jurisdictions aligned with global regulatory expectations, including FDA, EMA, MHRA, PMDA, PIC/S, and other applicable health authority requirements.

·       Lead audit readiness activities and provide oversight during regulatory inspections, including preparation, inspection management, response coordination, remediation planning, and follow-up of commitments.

·       Oversee the planning, execution, and reporting of self-inspection programs across GMP subsystems, including Quality Systems, Quality Operations, Production, Facilities and Equipment, Quality Control, MSAT, and Supply Chain.

·       Maintain and continuously improve self-inspection procedures, tools, and templates to ensure alignment with ICH Q10, 21 CFR Parts 210/211, and evolving industry and regulatory expectations.

·       Support global alignment on regulatory expectations, inspection approaches, and compliance practices by working closely with global quality, regulatory, and operational stakeholders.

·       Act as a trusted compliance advisor on complex quality matters, providing practical guidance that protects the organization’s licenses, regulatory standing, and reputation.

·       Provide training, coaching, and guidance on compliance topics to strengthen quality culture, regulatory awareness, inspection readiness, and data integrity across the organization.

Experience & Qualifications:

• Bachelor’s degree in for instance: Biochemistry, Life Science & Technology, Engineering and minimum of 12 years of relevant experience in related field.
• A Master’s degree can be substituted for 2 years of related experience.
• A Ph.D. degree can be substituted for 4 years of related experience.
• 12+ years of progressive experience in Quality Compliance, with a track record in self-inspection
• Deep expertise in utilities and critical systems, maintenance and calibration programs, and contractor-led service models.
• A minimum of 15 years of cGMP experience.
• Sound judgment and comfort operating in ambiguity—able to make decisions when precedent may not exist.
• Strong cross-functional leadership and stakeholder management
• Strong communications skills
• Excellent auditor skills.
• Strategic and critical thinking with quality rigor

.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.