Manager QC Services
Gilead
IT
6 gg fa

Job Description

Kite, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st century medicine : curing cancer.

This mission is at the heart of everything we do, from early research to product development.

We are one company at multiple locations. While it all started in Santa Monica, we now have several locations and facilities.

We are continuing to expand our corporate headquarters and our El Segundo manufacturing center is state-of-the-art. We continue to expand our global footprint and now have a European location in London and Amsterdam.

Currently we are in the process of building a new manufacturing site in Hoofddorp (near Schiphol).

We are seeking highly motivated individuals to support our efforts to set up the Manufacturing site in this exciting new area of cancer immunotherapy and delivering T-

cell immunotherapies to patients in the near future from this new site.

In this role you will work with the Quality Control Services team as the Manager, having oversight on the QC Services activities required to qualify the new facility and leading the daily operations of QC Services.

QC Services is a supporting unit within the QC department, providing services involving Data management, LIMS support, Sample management, Material management of the laboratories and Laboratory Equipment lifecycle management.

You will be reporting to the QC-Director.

Responsibilities (include but are not limited to) :

  • Responsible for setting up the Sample Allocation laboratory of the new manufacturing site
  • Establish user requirements for purchase, qualification and implementation of QC equipment for setting up the Sample Allocation laboratory and work with internal and external resources to maintain equipment in an optimal state
  • Manage the QC Services operation, ensuring processes provide high quality support for Quality Control and Operations while ensuring compliance of protocols, GMP’s and safety regulations
  • Manage personnel, including organizing and prioritizing daily tasks overseeing all daily operations :
  • Have oversight on Sample management activities : Ensure procedures and processes are in place to allow efficient transfer of samples from Manufacturing to QC and subsequent distribution into the different QC functions
  • Have oversight on and coordinate Data management activities : Review Trend analysis of all sorts of QC data (e.g. OOS and Invalid trending, Analytical data trending)Review metric information for use in continuous improvement of areas of responsibilityGeneration of CoAs for raw material and product release
  • Have oversight on and coordinate LIMS support in close collaboration with Quality Engineering
  • Have oversight on and participate in Laboratory equipment life cycle management : Review and approve URS / FRS and any other documentation generated for specification of laboratory equipment, utilities or systems.
  • Review draft operational SOPs for systems and equipment prior to the execution of Qualification Protocols. Approve operational SOPs for systems and equipment prior to approving the Operational Qualification Final Report.

    Oversight on routine maintenance and calibration of lab equipment and lab spaces

  • Have oversight on Material management in the QC laboratories : Responsible for the design, implementation and maintenance of the Kanban system for laboratory supplies
  • Provide Leadership, management, training and career coaching for QC Services staff
  • Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies, interact with agents from Regulatory agencies and participate in (Pre-Approval) Inspections
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Write and / or implement changes to controlled documents (e.g. Policies, SOPs, (Software) Specifications, etc)
  • Review proposed changes to systems, procedures and methods, as appropriate.
  • Provide updates at daily and weekly meetings
  • Other duties as assigned
  • Requirements :

  • Bachelor’s degree in Analytical Chemistry / Molecular Biology or equivalent preferred with 8+ years of QC experience in a technical role in the Biotech and / or Pharmaceutical Industry
  • 4+ years of managing QC group / department experience within the Biotechnology or Pharmaceutical industry.
  • Proficient in application of QC principles, concepts, Industry best practices and standards
  • Working Knowledge in Equipment qualification, calibration and maintenance in a cGMP environment
  • Working Knowledge of cGMP, GLPs, regulatory requirements for equipment lifecycle management pertaining to the Pharmaceutical Industry
  • Understanding of aseptic manufacturing
  • Proven analytical, conceptual skills and technical writing skills
  • Strong organizational, planning and problem solving skills. Able to manage competing priorities creating an effective team environment
  • Strong interpersonal, verbal and written communication skills are essential in this collaborative work environment. Able to influence without authority.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Ability to be flexible with schedule, and work overtime as needed
  • Hands-on, roll up your sleeves mentality
  • Proficiency in Microsoft Office applications
  • Willingness to travel to the US site for training purposes is a plus
  • More information?

    Would you like to know more before you apply? Please contact me, Janne Bruntink - talent acquisition specialist, via : jbruntink kitepharma.

    com. Or call our recruitment desk : +3120 237 45 91.

    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.

    For Current Kite Pharma Employees and Contractors :

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

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