Senior QMS professional - Clinical Supplies

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Do you have a high-quality mindset and a desire to deliver quality support for our trial product handling and supply chain processes in Novo Nordisk which is essential for our clinical trials? Are you eager to learn about how Novo Nordisk develops and run clinical trials? If yes, then we have the perfect opportunity for you! As part of Novo Nordisk’s R&D family, CMC Development makes a real difference for patients with chronic diseases across the world. We develop, manufacture, and distribute drug candidates for all Novo Nordisk non-clinical and clinical trials. The Position You will be Senior QMS professional in the Operation&Support team and overall responsible for supporting the processes in the team, department and across Clinical Supplies (CS) with regards to QMS tasks:
  • Plan and participate in audits and inspections
  • Write deviations and change requests
  • Be responsible for deviation trending in the department
  • Author SOPs and training material
  • Represent the department in the CS QMS group
  • Be responsible for the Quality Management Review in the department
  • Train and guide colleagues in deviations, change requests as well as SOP and training material writing
  • As Senior QMS professional you will be reporting to associate manager of the Operation&Support team. Qualifications You hold a master’s degree within life sciences such as pharmaceutical science, engineering or similar. You need to have a high-quality mindset and have experience in working with GMP, GDP and preferably also GCP. Ideally, you have:
  • 2-3 years of experience as a Process Supporter or similar from a regulated environment
  • Knowledge on how to navigate in a GMP regulated field with several stakeholders
  • Experience with documentation; skills within written documentation such as SOPs, training material, change requests and deviations
  • You are a team player and find motivation when reaching common goals. You are self-driven, flexible, take responsibility for your tasks and seek simple solutions. We expect that you are structured and able to plan your work in a dynamic workplace where priorities change, and new decisions are made. You communicate effectively and fluent in Danish and English. About the department Clinical Supplies Supply Chain Planning is a part of Clinical Supplies in CMC Development. We are responsible for the overall planning of the production, packaging, and distribution of products for Novo Nordisk clinical trials worldwide in close collaboration with the CMR organisation across the affiliates globally. The department consists of three teams, supporting the execution of clinical trials by forecasting/monitoring product demand, ordering product, planning the packaging/shipping of trial products and supporting the overall trial conduct at the clinical sites with a focus on trial product related processes and systems. Working at Novo Nordisk
    Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 60,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Christophe Poirel Madsen, +45 30776827 Deadline Apply before September, 16 2024. Please note that applications will be reviewed on an ongoing basis and interviews will be scheduled as soon as suitable candidates are identified. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Jobbet er oprettet på vores service den 7.8.2024, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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