Specialist, Quality Assurance

Описание вакансии

At Gilead, we’re creating a healthier world for all people. 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

We are seeking a highly motivated individual to join us as Specialist for Japan. You will work in the Quality as one of the members of Tech.Ops 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 manage local QMS, and other duties as assigned to comply with local legislation and company requirements. This position will be in Japan, reporting to Associate Director, Quality Assurance at Kite.

Responsibilities (including but are not limited to):

• Responsible for 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 manufacturing sites (in Japan and overseas) to address and resolve performance issues and quality events.
• Maintain metrics related to Quality of Commercial Cell Therapy Product(s).
• Support inspection readiness plans and interact with regulatory authorities (PMDA, etc.) during inspections on Kite related matters
• Lead or support, product complaints, deviations, or recall/Field Corrective Actions (reporting to Japan health authorities (PMDA, etc.))
• Support inspection readiness plans and interact with regulatory authorities during inspections on Kite related matters
• Support Lead for affiliate Kite GMP self-inspections
• Conduct and manage internal or external audits (including the hospital audit).
• 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 biology, engineering or related field preferred.
• Minimum of 2 years progressive experience in medical, pharmaceutical or biologics quality systems’ roles or equivalent.
• Experience with product import lot disposition, deviation and change control management preferred.
• Proficiency for reading and writing in English.
• Strong working knowledge of and ability to apply cGMP principles in conformance to Japanese and US preferred.
• 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 is beneficial.
• Comfortable interacting with regulatory agencies as needed.
• Demonstrates proficiency in Microsoft Office applications.
• Comfortable use of web-based systems and digital tools as part of daily work operations.
• Excellent interpersonal, verbal and technical writing, communication and interpersonal 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.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.