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Quality Assurance Manager


At TRACER we strive to make the current drug development process faster, more cost-effective and efficient for everyone involved. As part of our growing efforts to change the drug development landscape and keep quality standards, we are now looking for a Quality Assurance Manager to join our team and accelerate (y)our growth even further.

As a company we believe that we need to create an environment unlike any other to attract, motivate and grow people bold enough to change the drug development industry with us. A place where extraordinary people get the autonomy to use and develop their ideas and talent to bring TRACER and themselves to the next level.

From day one you will notice that we are not limited by things that we have not done before. We all possess a drive for continuous learning and an entrepreneurial mindset. This is the key to our growth and the reason why people like you and I can thrive at TRACER and are not limited in our potential. If this sounds like a place where you fit in, then definitely keep on reading.

As a Quality Assurance Manager, you will

  • Ensure compliance of all our processes to the correct regulatory standards
  • Implement, sustain and continually enhance our quality management system, in line with ISO 9001 and 27001 certifications
  • Organize, prepare and lead internal and vendor audits and reviews
  • Responsible for SOP and document management
  • Be the point of contact for our quality strategy for all stakeholders
  • Find the right balance between the level of registration and practical feasibility
  • Conduct risk assessments for clinical and operational processes
  • Manage non-conformance investigations and implement corrective and preventive actions (CAPA)

 

Ideally, you fit the following profile

  • Experience with quality management in the pharmaceutical industry, preferably in a clinical research environment and experience with a QMS electronical system
  • You have experience with ISO 9001 and ISO 27001
  • Aware of GCP guidelines and other applicable regulations for the conduction of clinical trials (EMA and FDA guidelines)
  • You possess a high level of responsibility, influence and accountability
  • You actively engage team member to translate quality control plans into practical implementations
  • You are able to set priorities, even in demanding situations that come with a growing organization
  • You do not ‘stop’ until things have been organized, your attention to detail is spot on
  • You are dedicated to continuous learning
  • You speak, write, and read fluently in Dutch and English (must)
  • Located in Nijmegen or surroundings

Nice to haves

  • Knowledge of molecular imaging technologies
  • A love for food and the good life

What we offer you
A salary of €3.800,- gross per month based on a fulltime position. But besides a paycheck and appreciation we have much more for you in store.

  • Unlimited vacation days. We trust your judgement to take what you need when your work allows it. ‘No-brainer’ at TRACER.
  • A well-arranged pension plan. Your financial (far) future should also be covered.
  • Flexibility in working hours. We encourage interaction with colleagues at the office, but understand the need for flexibility. Whether you need to pick up your kids early or prefer to work from home for the day, you can manage your time as your activities permit.
  • Autonomy in your work and the responsibility that comes with it
  • 8% holiday pay
  • Plenty of room for initiative and personal development to achieve your own growth within TRACER. We recognize talent and strengths, listen to your ambitions and set goals together to realize your development
  • A dedicated team with a strong entrepreneurial mindset who all feel responsible for the results as a team driven by individuals
  • Short communication and reporting lines. No endless emails to different departments to get things done. Besides the fact that we like seeing each other at the office, it’s easier to just walk in and talk to the people you need.
  • Quarterly team events inspired by a company bucket list and lots of food. We like spending time together in and out of the office  What’s on your bucket list?

What to expect from us after you apply?
You will receive a confirmation email within 2-3 working days. In this email you can find more information about the next steps for this position. Besides getting to know each other, our hiring process for the Quality Assurance Manager position includes a reference check. We always ask anyone joining our team to submit a Certificate of Conduct (VOG) before signing a contract.

Want some more information before you apply? Reach out to Marjolein, our Director Human Resources, at HR@tracercro.com. Feel free to add your CV and motivation if you want.

Send us your application

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