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In support of developing our innovative NK cell therapies, we are looking for Quality Control Manager based in Amsterdam, the Netherlands.

At Kiadis, we are leveraging the natural strengths of humanity and our collective immune systems to source the best cells for life. Our NK cell (natural killer cell) research and development programs and partnerships are at the cutting-edge of the industry, paving the way for new and exciting therapies, in immuno-oncology and beyond.

 

Are you interested in setting-up a Quality Control lab and work together with a multidisciplinary team? Is organizing in your nature & do you get energy from planning things to a T? Do you like working in a constant changing environment? Read on.

 

The role

As the QC Manager, you are responsible for the management of the Amsterdam quality control laboratories, QC data review, method validations, equipment qualifications, laboratory investigations, quality procedures, method performance monitoring. In your day-to-day you will:

  • Be the operational head of Quality Control laboratories, responsible for In-process control and release testing of medicinal products produced under GMP.
  • Advise / Provide support to Tech Ops, PD, AD and QC.
  • Build and maintain a high-performing team of QC (Senior) Analysts who have direct responsibility for QC testing.
  • Manage the QC lab resources to support manufacturing schedule and ensure timely execution of release testing and other analytical activities.
  • Assure compliance of equipment, methods and testing with GMP regulations and regulatory expectations.
  • Ensure compliance with the Kiadis QMS- own and/or manage quality records eg SOPs, Deviations, OOS, CAPAs etc.
  • Support internal and external audits and inspections.
  • Manage and maintain the QC lab facilities and equipment.
  • Perform and/or oversee QC lab equipment qualification.
  • Ensure implementation of appropriate QC lab safety procedures.
  • Drive continuous improvement within the QC lab.

 

Quality

Our Quality department works with a strong motivation to deliver safe and effective personalized medicine to our patients. Our team of highly-skilled professionals ensure compliance on many levels, they also train our employees, which has resulted in quality being a key component of our company culture. As part of the Quality team, you will work with a high sense of urgency, work to continuously improve our processes and collaborate with different people from all over the world. Join us and see for yourself how you can make an impact. 

 

The ideal candidate

We are looking for someone that has experience with managing a Quality Control team and that is eager to not only set-up the QC lab but also work on continuous improvement. Our ideal candidate meets the following requirements:

  • Education: PhD in a biological discipline
  • Experience: >8 years in method development and quality control in biotech/pharma industry
  • Specific skills:
    • Experience in the development of cell-based methods for GMP purposes.
    • Good understanding of analytical variation and complexity and its impact on product quality.
    • Experience in liaising with different departments, such as QA, Manufacturing and Regulatory Affairs.
    • Minimal 5 years of experience in people management.
    • Thorough knowledge of the EU/US and other relevant regulatory requirements
    • In depth knowledge of ICH guidance’s
  • Personal characteristics / interpersonal skills
    • Outstanding interpersonal and communication skills as well as presentation skills.
    • Great project management skills and ability to work well under pressure and with ambiguity.
    • Demonstrated team player with experience contributing to multi-disciplinary project teams and ability to work with minimal supervision.
    • Ability to manage multiple priorities with aggressive timelines at a high level of productivity
    • Must be highly organized and possess excellent attention to detail
  • Fluency in English, other languages are a plus.

 

What we offer

People from all over the world, together as one team, contribute to improving the lives of patients every day. We offer an exciting position in an innovative, dynamic and inspiring environment where you'll receive a competitive remuneration package, autonomy and the opportunity to make your own mark within the organization.

 

We create an environment where ideas are shared, experiences are impactful, and talent is developed. Because of our inclusive and family-like environment, you will always have the feeling of belonging & appreciation.