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Senior Manager, QA - Site Qualification, EU

Quality | Amsterdam, Netherlands | Full Time

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 recognise and kill tumours. Kite Europe is headquartered in Stockley Park, UK and is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs

Position Summary

We are seeking highly motivated individuals to join us as (Senior) Manager(s), Quality Assurance - Site Qualification in the EU.  You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.  This individual will work cross-functionally to assist with the development and implementation of a qualification and monitoring program for medical apheresis and treatment centres that supports Kite’s rapid expansion of our first commercially marketed cell therapy product in the EU.

The position is part of the European Technical Operations team that is located in Amsterdam, the Netherlands.

Key Responsibilities (include but are not limited to):

  • Assist in management of the collection app system.
  • Assess and approve any changes to collection app, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained
  • Assist in the management of an apheresis and treatment centre (ATC) qualification process that will use risk-based tools for qualification, training, monitoring and disqualification.
  • Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
  • Perform selection audits, qualify and monitor compliance to qualification requirements.
  • Maintain the monitoring schedule and approved ATC list.
  • Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
  • Assist in management of the collection system.
  • Assess and approve any changes to collection app, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained
  • Assist in development, implementation and management of ATC management system (Oracle Agile)
  • Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
  • Ability to travel up to 40%
  • Perform other duties as assigned

                Key Requirements

  • Bachelor’s degree in Nursing, biological sciences, nursing, medical technologist or related field
  • Minimum of 8 years progressive experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centres, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems’ roles.
  • Experience managing external suppliers, blood banks, and plasma centres.
  • Medical center or pharmaceutical auditing experience preferred.
  • Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.
  • Previous experience presenting and responding to a regulatory agency or certification audits preferred.
  • Proficient in MS Word, Excel, and PowerPoint
  • 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 is an equal opportunity employer based office in Amsterdam.  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.

No phone calls please and no agencies or recruiters.

 

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