Manager, Quality Operations

Job Summary

Kite Pharma is seeking a highly motivated Manager, Quality Operations to join their North America Regional Quality Operations team, focusing on CAR-T cancer immunotherapy. This role involves cross-functional collaboration to support the qualification and monitoring program for apheresis collection and treatment centers, crucial for the company's expansion.

Job Responsibilities

• Assess and approve changes to critical systems like Apheresis Collection Module, courier tracking, and order processing to maintain validated states.
• Assist in managing the apheresis and treatment center (ATC) qualification process, utilizing risk-based tools for qualification, training, monitoring, and disqualification.
• Collaborate with Commercial Operations for routine management of ATC relationships and Supply Chain for courier qualification and monitoring.
• Perform various audits and monitor compliance with qualification requirements.
• Maintain the monitoring schedule and approved ATC list.
• Assist in resolving ATC and courier issues, discrepancies, and investigations.
• Support or own quality records, including Deviations, CAPA, and Change Control.
• Aid in the development, implementation, and management of the ATC management system (GVault).
• Support inspection readiness plans and interact with regulatory agencies during inspections related to ATCs.
• Ability to travel up to 40%.

Key Qualifications

• Basic Qualifications: Bachelor's Degree with Six Years' Experience, OR Master's Degree with Four Years' Experience, OR PhD/PharmD.
• Preferred Qualifications: Bachelor's degree in biological sciences, nursing, medical technologist, or related field. 8 years of progressive experience in a medical or pharmaceutical environment (nursing, apheresis/transplant/infusion centers, blood banks) OR pharmaceutical, vaccines, or biologics quality systems roles. Minimum 3-5 years of quality assurance experience. Experience managing external suppliers, blood banks, and plasma centers. Medical center or pharmaceutical auditing experience preferred. Experience in Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred. Previous experience in deviation management, CAPA development, and change control preferred. ASQ Certified Quality Auditor preferred. Strong working knowledge of GMP and FACT/AABB standards. Previous experience presenting to and responding to regulatory agency or certification audits preferred. Proficient in MS Word, Excel, and PowerPoint. Excellent interpersonal, verbal, and written communication skills. Ability to work independently in a fast-paced small company environment with minimal direction and adjust workload based on changing priorities. Must be self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description.

People Leader Accountabilities

• Create Inclusion: Understand the business value of diverse teams, model inclusion, and embed diversity values in team management.
• Develop Talent: Coach employees on current performance and future potential, ensuring they receive feedback for growth and realization of purpose.
• Empower Teams: Connect the team to organizational goals and purpose, provide support, remove barriers, and connect them to the broader ecosystem.

Compensation and Benefits

The salary range for this position is $123,930.00 - $160,380.00. Compensation is based on factors like experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package including company-sponsored medical, dental, vision, and life insurance plans.

About Kite Pharma

Kite Pharma is a biopharmaceutical company dedicated to developing innovative cancer immunotherapies, specifically CAR T-cell and TCR engineered cell therapies. Their goal is to provide rapid, long-term durable responses and eliminate the burden of chronic care. Kite is based in Santa Monica, CA. For more information, visit www.kitepharma.com and follow @KitePharma on Twitter.

Equal Employment Opportunity

Kite Pharma is committed to equal employment opportunities and fostering an inclusive work environment. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity, veteran status, or other protected characteristics. Reasonable accommodations are available for individuals with disabilities during the application process. Information on employee rights regarding polygraph protection and family and medical leave is available.

Key Skills/Competency

• Quality Operations
• CAR-T Immunotherapy
• Apheresis Center Management
• GMP Standards
• Regulatory Compliance
• Auditing
• CAPA Management
• Change Control
• Supplier Management
• Quality Assurance