Specialist III, Quality Assurance (SQM - Materials)

Specialist III, Quality Assurance (SQM - Materials)

We are seeking a highly motivated individual to join us as a Specialist III, Quality Assurance. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. This individual will work cross functionally to execute and improve the Supplier Quality Management (SQM) program that supports Kite's rapid expansion to commercial manufacturing and first marketed product. This individual will foster and collaborate with partners in Quality, Supply Chain, Process Development, Commercial and Clinical Operations to assist in execution and maintenance of SQM Quality Records, resolution of quality issues and enhancements to the Kite supplier base. This role will be a hands-on resource reporting to the Associate Director, Quality Assurance (SQM-Materials).

Responsibilities (include but are not limited to):

• Assist management in the enhancement of supplier qualification process that will use risk-based tools for classification, qualification and monitoring.
• Perform or support audits of raw materials and component suppliers. Work with suppliers, as needed, to identify and implement responses to observations.
• Support the development of supplier Quality Agreements (in collaboration with SQM, Legal and Supply Chain) and/or updates for change notification.
• Assist requestors with new specification development or manage update to existing specification.
• Participate in selection and qualification of new suppliers and manage the onboarding of new materials and suppliers.
• Assist in the management and execution of supplier change management for raw materials and components.
• May own change control and/or change control task to manage new materials and material changes.
• Assist in maintaining the audit schedule and approved supplier list (Agile and Oracle EBS) for assigned suppliers.
• Support or act as Quality contact for the management of investigations and resolution of supplier issues and discrepancies (SCARs), and may lead/manage the investigations to resolve the issues.
• Gather or compile Supplier Performance Monitoring and SQM Quality Management Review metrics.
• Support inspection readiness plans on SQM-related matters, as needed.
• Ability to travel up to 20%.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree and 6+ years of experience or Masters and 4+ years of experience in a scientific or technical field in a pharmaceutical, cell therapy, biologics, or medical device supplier quality management role, or other quality role requiring performance of compliance audits. Cell therapy, biologics or vaccines experience preferred.
• Experience with AGILE and ORACLE EBS preferred.
• Experience auditing suppliers for raw materials, sterile components, primary and secondary packaging components and sterilization facilities. ASQ Certified Quality Auditor preferred.
• Experience in identifying, writing, evaluating and closing investigations, with strong familiarity with root cause analysis tools.
• Working knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
• Proficient in MS Word, Excel, and Power Point.
• Strong interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

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.

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