Magnet.me  -  The smart network where hbo and wo students find their internship and first job.

The smart network where hbo and wo students find their internship and first job.

This opportunity has expired. It is therefore no longer possible to like or apply.

See similar opportunities instead

(Sr) QA Specialist

Posted 25 Mar 2024
Work experience
4 to 6 years
Full-time / part-time
Full-time
Degree level
Required languages
English (Fluent)
Dutch (Fluent)

Your career starts on Magnet.me

Create a profile and receive smart job recommendations based on your liked jobs.

Job Description

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

We are currently looking for our new (Sr.) Specialist, Quality Assurance, Site Qualification Systems. You will work within the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. You will work cross functionally to assist with the monitoring program of qualified apheresis center and treatment sites (ATC) and Document Control activities that supports Kite’s rapid expansion to commercial manufacturing and first marketed product. Furthermore you will be actively communicate with ATC. This role will be a hands-on resource reporting to the Sr. Manager, QA Site Qualification EU. This role is based in Hoofddorp, nearby Amsterdam in the Netherlands.

Responsibilities (include but are not limited to):

  • Assist in the development and management of the site qualifications monitoring and oversight process of authorized hospitals, including drafting and assessing (quarterly) monitoring reports
  • Assist in the management of an electronic system (Agile) to maintain and track site qualification activities
  • Activation of qualified sites in the Kite EBS
  • Assist with resolution of ATC issues and discrepancies, and the investigations to resolve the issues
  • Assist with document and management of change requests and Change Notifications from ATC, change control, deviation and CAPA systems
  • Collaborate with cross-functional departments to ensure timely implementation of quality records
  • Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed
  • Assist in drafting and closing Quality Agreement with ATC
  • Help on the harmonization of Standard Operation Procedures across the region and ensure compliance to Doc Control systems
  • Perform other duties as assigned

Requirements:

  • Bachelor’s degree in biological sciences, nursing, medical technology or related field
  • Preferably several years of experience in pharmaceutical or biologics quality systems’ roles; cell therapy, biologics, blood/human tissue or vaccines
  • Experience with quality management systems, and information system development and implementation
  • Cellular & Gene Therapy Products or Blood and Blood Product experience preferred
  • Strong working knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
  • Previous experience presenting and responding to regulatory agency audits, preferred
  • Proficient in MS Word, Excel, and Power Point
  • Comfortable and enjoy working with digital (quality) systems
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated, detail-oriented, and willing to accept responsibilities outside of initial job description
  • Excellent spoken and written English
  • Speaking and writing another European language is preferred

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose.

Apply now!

Would you like to know more before you apply? Please visit us at www.kiteamsterdamcareers.com or contact Helena Buiter - Hoven, Team Lead Talent Acquisition at CareersEU@kitepharma.com.

Only candidates in possession of a valid EU work permit will be considered.

Recruitment agencies: We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.

#li-HH1

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.

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 the past three decades, members of our team have been at the forefront of cancer immunotherapy. Today, we are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago.

Pharmaceutical
Hoofddorp
2,000 employees