Clinical Quality Partner

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Søborg

Do you dream of using your GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Do you have a ‘can-do’ attitude and do you want to support high quality in the development of innovative treatments for patients? Then you could become our new GCP Advisor. Apply now and join us for a life-changing career! About the department
Clinical Compliance is one of three sister departments in Clinical Quality & Compliance, which is part of R&D Quality in Novo Nordisk. We play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes. In Novo Nordisk, we have an ambitious drug development program, and we work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society. In Clinical Quality & Compliance, we support the clinical development organisation globally and drive many activities such as:
  • Being Clinical Quality partners to key projects and line of business and taking part in due diligence activities when looking at acquiring new assets,
  • Providing GCP support and leading the GCP inspections,
  • Reviewing and approving audit CAPA plans
  • Performing vendor assessments, trying to impact external clinical requirements and sharing Clinical Quality and GCP knowledge
  • Taking part in cross organisational improvement projects and providing general quality & compliance support
  • We are busy and we are on an exciting journey bringing quality on top of the agenda throughout the R&D organisation – and maybe you are the one to join us on this journey? The position
    The position entails serving as the Quality Partner for colleagues involved in clinical trials/programs, such as clinical trial management. As such, the selected individual will be the sole point of contact for all quality-related matters. Our new Quality Partner will be:
  • Supporting clinical programs and trials in a key project from start to finish. Your support will mainly be within GCP and external requirements within clinical trial conduct, but you will also be the contact between the projects and the subject matters experts (SMEs) in our area
  • A part of the network of quality partners in our own area
  • Involved in other activities in the department such as improvement/optimisation projects and supporting our other stakeholders with GCP advice
  • You will be part of a dynamic and hybrid team, with colleagues working from Søborg and Boston. This position is based in Søborg. The position offers high impact, flexibilty and you are expected to take ownership and responsibility for setting the right quality level in the global organisation. Qualifications
    Our ideal candidate has:
    • Degree in pharmacy, medicine, science or similar
    • At least 5 years of experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations
    • Experience within clinical quality assurance, trial management/monitoring, or GCP Audits
    • A strong command of written and spoken English We are looking for someone who can take a positive and pragmatic approach to problem solving and is eager to create, optimise and simplify processes around. Proactivity, courage, strong communication and interpersonal skills are highly valued. Our ideal candidate is organised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature. It is important that you are a team player, but can work independently and you thrive working across departments in an international organisation. Working at Novo Nordisk
    At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
    For further information, please contact Lene Tommerup +45 3075 7779 or Lisbeth Bonefeld +45 30758096. Deadline
    17 August 2023
    We will be screening, interviewing and hiring on an ongoing basis.
    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.


    Information og data

    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 12.5.2023, 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.
    • Øvrige
    • Søborg

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