Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.

We are seeking a highly motivated individual to join us as Associate Director, Quality Assurance reporting Directly to the Head of Global QC Organization. In this position, you will direct the activities of the Quality Assurance department for Global Raw Materials and Reagents Center of Excellence (COE), Corporate Micro COE, Commercial Technology Innovation COE, and Analytical Portfolio and Lifecycle Management groups to ensure conformance to Kite Pharma quality standards and government regulations. You will also provide objective evaluation of process performance and product quality and develop staff for continual contributions towards plant quality goals.

Responsibilities (include but are not limited to):

• Lead the Quality Assurance and Quality Systems staff including recruitment, performance management, hiring along with staff training and development.
• Review batch-related documentation and ensure resolution of issues to release product.
• Oversee the raw material disposition process.
• Host and manage regulatory inspections, internal audits, and external audits from partners.
• Participate and provide leadership at the site level and at the corporate level.
• Ensure all Deviations and CAPAs under your responsibility are initiated, investigated and resolved.
• Chair the Material Review Board meetings for Raw Materials and Reagents (Manufacturing and QC) to ensure non-conforming raw materials are appropriately dispositioned.
• Ensure change controls, deviations and CAPAs are initiated, evaluated and implemented appropriately for all regulated changes.
• Manage Quality Systems and Compliance.
• Develop and implements Quality on the floor process.
• Ensure process control measures are in place and followed in the Centre of Excellence labs
• Manage internal site audits ensuring adherence to audit schedule and timely closure of findings.
• Maintain and report monitoring and control metrics for process performance and product quality.

Basic Qualifications:

• Advanced scientific degree (i.e. MD, PharmD, PhD) and 2+ years’ experience in quality or manufacturing experience in a pharmaceutical or biologics operation OR
• Master’s Degree and 8+ years’ experience in quality or manufacturing experience in a pharmaceutical or biologics operation OR
• Bachelor’s Degree and 10+ years’ experience in quality or manufacturing experience in a pharmaceutical or biologics operation OR
• High School Degree and 14+ years’ experience in quality or manufacturing experience in a pharmaceutical or biologics operation

Preferred Qualifications:

• Management/leadership experience
• Working knowledge and ability to apply cGMP in conformance to U.S., EU, and ROW standards, and including compendial requirements in different markets
• Ability to effectively negotiate and build collaboration amongst individuals
• Demonstrated ability to develop, coach, and mentor key employees
• Excellent interpersonal, verbal and written communication skills
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

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