For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
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 Gilead and help create possible, together.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.
For the activities in Japan Kite is currently looking for a talent as it focuses on developing the Cell Therapy program in Japan in support of providing maximum access to patients with unmet needs.
We are seeking a highly motivated individual to join us as Manager or Sr. Specialist for Japan.
You will work in the Quality and collaborate with Commercial teams in supporting commercial operation in this exciting new area of cancer immunotherapy.
This individual will work cross functionally to implement, improve, and execute the Good Quality Practice for Kite Japan.
Your responsibilities will include local release of products imported into Japan from the manufacturing sites, managing local QMS, and other duties as assigned to comply with local legislation and company requirements.
Responsibilities (include But Are Not Limited To)
Responsible for market release of Cell Therapy Finished Products in Japan and quality monitoring of importation of Cell Therapy Finished Products in Japan
Maintain and update local QMS/ GQP to adhere local regulation (e.g. PMDA)
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 information, guidance or reports to management when specific compliance issues arise
Oversee and interface with Japan CMO to address and resolve performance issues and quality events.
Maintain metrics related to Quality of Commercial Cell Therapy Product(s)
Act as Japan lead or support for Japan health authorities (PMDA, etc.) inspections, product complaints, deviations, or recall/Field Corrective Actions (reporting to Japan health authorities (PMDA, etc.)
)Responsible for tracking and reporting metrics
Support inspection readiness plans and interact with regulatory agencies during inspections on Kite related matters
Lead for affiliate Kite GMP self-inspections
Conduct and manage internal or external audits
Work with Regional and Corporate (Quality) teams, as needed
Collaborate cross-functionally with the Japan Gilead affiliate to fulfill all responsibilities as MAH.
Perform other duties as assigned
Requirements
Bachelor's degree in medicine, dentistry, pharmacy, veterinary medicine, or biology or related field
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 for reading and writing in English and Japanese
Strong working knowledge of and ability to apply cGMP principles in conformance to Japanese and US
Broad experience across areas like Quality Assurance and/or Quality Systems and understanding of parenteral and aseptic operations is beneficial
Previous experience presenting and responding to regulatory agency inspections
Comfortable interacting with regulatory agencies as needed
Proficient in MS Word, Excel, and Power Point
Comfortable using web-based systems and digital tools as part of daily work operations.
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.
Sign up to follow @Kite Pharma on Twitter at
For Current Gilead Employees And Contractors
Please apply via the Internal Career Opportunities portal in Workday.
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