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In support of developing our innovative NK cell therapies, we are looking for Quality Assurance Director 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 ready to build a great quality system for our in-house manufacturing facility in order to delivers our amazing work to patients worldwide? Do you have strong knowledge of GMP and worked on site set-up o expansions before? Are you a strong communicator, charismatic influencer and able to effectively manage leadership encounters with a high sense of integrity? Read on.

 

The role

As the QA Director, you will be responsible for the coordination of all quality operations at the Amsterdam location including outsourced and in-house manufacturing. Your main focus is to ensure that the production and quality control activities are performed in compliance with cGMP/GDP requirements, in order for us to deliver the best quality product to patients. In your day-to-day you will:

  • Building cross functional relationships to support Quality Operations throughout Kiadis organization and at outsourced manufacturing and/or testing laboratories.
  • Ensuring the production and control activities performed at Kiadis manufacturing and testing locations are in compliance with GMP requirements.
  • Manage the QA Ops resource scheduling to ensure sufficient support to on-going manufacturing and testing.
  • Host regulatory inspections at Kiadis/CMO manufacturing and testing locations.
  • Perform audits of the Kiadis suppliers and service providers as required.
  • Provide guidance and support to Kiadis manufacturing and testing staff concerning compliance with relevant quality and regulatory policies and the development of strategies to improve quality working practices and systems.
  • Daily management of Kiadis quality operations, to include executed manufacturing record and data review, investigation support and regulatory inspection support as it relates to Kiadis products.
  • Supporting International Regulatory Inspections- managing preparation and any follow-up actions
  • Oversight of Kiadis manufacturing and QC release testing laboratories operations.

 

Quality Assurance 

Our Quality Assurance 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 Assurance 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 a strong background in Quality Assurance, experience with investigations and that likes being part of a dynamic organization. Our ideal candidate meets the following requirements:

  • HBO/University degree in biomedical and/or life sciences
  • Minimum of 8 years of Pharmaceutical/biotechnology experience. 
  • In depth experience with Quality Systems and Quality Management programs, with an emphasis on Quality Control and Analytical Method Validation. 
  • In depth knowledge of EU & FDA regulatory agencies expectations
  • A detailed and complete knowledge of international cGMP. 
  • In-depth knowledge of international regulation inspections 
  • Maintain expert knowledge with current international pharmaceutical/biotechnology industry trends
  • Proficient computer skills
  • Previous managerial experience Is mandatory.
  • 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.