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QA Specialist III, Change Control & Projects

Aalsmeer, Netherlands

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Kite we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

We are seeking a highly effective Quality Assurance professional with demonstrated knowledge of, and experience in, e nd to e nd (bio) pharmaceutical manufacturing operations .

Department Description

As QA Specialist (III) Change Control & Projects, you’ll be participating in a team in which people of all backgrounds and experiences are respected, and working together and where focus on saving lives, by providing the cure for cancer, is a daily activity. You’ll be reporting to the Sr. Manager Quality Assurance Change Control & Projects

Your new role

In this new role you will support the team with a variety of facility, manufacturing process, test method, laboratory technique, and material changes, improvements, and innovations. Your will be responsible for ensuring that such changes and projects are executed in accordance with sound change management principles and Kite procedures.

Your profile

  • Bachelor’s or master’s degree in Pharmacy , Biotechnology, Biochemistry or equivalent.

  • You have an extensive work experience in cGMP environments and GMP documentation / compliance reviews.

  • You have advanced knowledge of change management principles including industry standard QMS applications ( preferred )

  • You posses proficient knowledge of Project Management and OE/CI ( preferred)

  • You re proficient in at least two of the following Quality System Elements

    • Laboratory systems and compendial methods including method transfer activities ( preferred )

    • IT infrastructures and solutions including EBR and ERP ( preferred )

    • Facilities & Equipment (expansion / construction processes)

    • Materials Management (incoming goods, Master Data Management, Warehousing)

    • Production systems and processes (ATMP or traditional Sterile dosage forms)

    • Packaging and Labeling systems

    • Contamination control / sterility 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. 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 . Sign up to follow @KitePharma on Twitter at .

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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