Manager/ Specialist Quality Assurance

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Job Description
Specific Responsibilities:
Essential Functions:
Manager/ Specialist Quality Assurance
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, and group company of Gilead Sciences Inc. 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. For the activities in Japan, Kite collaborates with Gilead Sciences KK, and is currently adding additional talent as it focuses on developing the Cell Therapy program in Japan in support of providing maximum access to patients with unmet needs.
Position Summary
We are seeking a highly motivated individual to join us as Manager, Quality Assurance for Japan. You will work with the Quality teams including Japan GQP QA and Commercial teams in supporting our efforts in this exciting new area of cancer immunotherapy. Your responsibilities will include local release of products imported into Japan as marketing authorization holder “Gilead Sciences KK(GSJ)” and other duties as assigned to comply with local legislation and company requirements. This position will be in Japan, reporting to the Kite Quality Assurance manager at GSJ.
Responsibilities (include But Are Not Limited To):

• Act as back up for Quality Assurance Manager (Hinseki) at GSJ
• Collaborate with cross-functional departments to ensure timely implementation of quality processes
• Release of Cell Therapy Finished Products in Japan and Quality monitoring of importation of Cell Therapy Finished Products in Japan when applicable
• Establishes quality strategy for Kite/GSJ products and aligned with GQP QA
• Build and maintain the Quality agreement and processes between Kite, Supplier and GQP QA
• Maintain Standard Operating Procedures (SOPs) to ensure quality objectives are met.
• Provides QA oversight and approves deviations, change controls and product complaints investigations for the manufacture, packaging and shipping events impacting Cell Therapy Products for Japan when applicable
• Provides necessary information and reports to GQP QA for awareness or approvals to meet regulatory requirements and internal procedures when applicable
• Works on routine QA operations such as Release, Change Control, Deviation, Product Complaint, Quality Documents creation and revision, training
• Oversee Japan CMO for validation/qualification activities and manufacturing, quality controls.
• Maintain metrics related to Quality of Commercial Cell Therapy Product(s)
• Assist to prepare and make a response for GCPT inspection by PMDA
• Assure Kite/Gilead business systems are developed, support and maintain validated state for GCPT/GDP activities.
• Support inspection readiness plans and interact with regulatory agencies during inspections on Kite/GSJ related matters
• Work with Regional and Corporate (Quality) teams, as needed
• Collaborate cross-functionally with GSJ/Kite to fulfill all responsibilities as MAH.
• Ensure clear roles and responsibilities between Kite and GSJ QA functions
• Work with the Site Qualification team to ensure Cell Therapy related local requirements are met
• Perform other duties as assigned
  

Essential:
Knowledge, Experience & Skills:
Desirable:
Requirements:

• Bachelor’s degree in medical technology, biological sciences or related field; Master’s degree preferred
• Minimum of 5 years progressive experience in medical, pharmaceutical or biologics quality systems’ roles
• Experience with product import lot disposition, deviation and change control management preferred
• Proficiency in English and Japanese
• Strong working knowledge of and ability to apply cGMP/GCPT/GQP principles in conformance to Japanese standards
• Broad experience across areas like Quality Assurance and/or Quality Systems and understanding of parenteral and aseptic operations is beneficial
• Comfortable interacting with regulatory agencies as needed
• Proficient in MS Word, Excel, and Power Point
• Demonstrated ability to develop, coach, and mentor employees
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company 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 Pharma, an equal opportunity employer. Kite Pharma is headquartered in Santa Monica, CA.
Kite Pharma offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.
To learn more about us, please visit our website at www.kitepharma.com
Sign up to follow @Kite Pharma on Twitter at www.twitter.com/kitepharma
No phone calls please and no agencies or recruiters.
For Current Gilead Employees And Contractors:
Please log onto your Internal Career Site to apply for this job.