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Quality Systems Manager

Mol
  • Outline the quality policy for the NURA radiopharmaceutical programme
  • Design, implement, train and improve pharmaceutical quality systems for our various activities
  • Ensure compliance with applicable laws and regulations, and interact with competent authorities
Apply now
Management & Operations

Will you come and help us in our fight against cancer?

With its new NURA programme, SCK CEN significantly increases its contribution to the fight against cancer.
NURA contributes to the development and supply of next-generation radiopharmaceuticals for treating different types of cancer, in cooperation with clinical and industrial partners.
We are looking for a Quality Systems Manager to support the NURA programme.
Your responsibilities include, but are not limited to:

  • Develop, coordinate, and control NURA quality policies
  • Develop and implement effective, practical and robust pharmaceutical quality systems to ensure efficiency and compliance (documentation, data integrity, CAPA, complaints, deviation and OOS, change control, GMP compliance…)
  • Establish Quality Systems design requirements by providing technical information
  • Ensure seamless integration of NURA Quality Systems in the corporate quality system, and enable supporting departments
  • Interact with regulatory agencies
  • Manage quality systems and identifies areas for continuous improvement
  • Conduct quality systems training of personnel
  • Investigate system failures and ensure successful resolution
  • Maintain quality systems' inspection readiness
  • Participate in investigations, host or support audits and inspections

To join this frontier, you'll need

  • Master's degree in engineering, pharmaceutical sciences or PhD in sciences or engineering sciences
  • Excellent communication and management skills to work in a multidisciplinary team in an international environment
  • Great writing and documentation skills
  • Experience in a nuclear environment is an asset
  • At least 5 years of experience in a GMP environment
  • At least 5 years of experience in a QA job
  • Passionate with an entrepreneurial spirit
  • Willing to work in supervised and controlled areas where radiation protection measures apply

Deadline

Contact
Daan Caeyers
daan.caeyers [at] sckcen.be