GCP Advisor Specialist for Clinical Inspections

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Søborg

We are expanding our Clinical Inspections team in Denmark. Do you dream of using your solid GCP knowledge, process optimisation skills, and quality mindset in a highly professional and engaged global environment? Can you bring a ‘can-do’ attitude to successfully lead the clinical inspection process – keeping calm under pressure and with an ability to spread that calmness to people around you? Then you could be our new GCP Advisor Specialist. Apply now and be part of Life-Changing Careers at [xxxxx]! About the department Clinical Inspections is one of four sister departments in Clinical Quality, 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. At [xxxxx], we have an ambitious drug development program, and we work in a global setting with a focus on delivering viable products that make a difference to patients and ultimately benefit society. The position You will be part of a team that supports the global clinical organization before, during, and after inspections and provides leadership and guidance to reach the best possible outcome of our inspections. The department's core activities consist of:
  • Leading the clinical inspection process – providing training, tools, and support
  • Hosting or co-hosting sponsor GCP inspections from health authorities
  • Facilitating that solid CAPAs are defined and implemented for inspection findings
  • Knowledge sharing to the global organization on inspection findings and learnings
  • Charing global inspection readiness activities
    • Apart from these core activities, you may also have cross-functional responsibilities within the Clinical Quality Area. Here, we support the trial teams globally in a proactive manner, ensuring that [xxxxx] is following GCP and other relevant external and internal requirements in an optimal way. We participate in improvement projects, provide GCP advice and training, handle potential serious breaches, and ensure proper follow-up on findings from GCP audits. You will be part of a dynamic area, where the positions offer high impact, and where you are expected to take ownership and responsibility for setting the right quality level in the global organisation. The open position is located in Søborg, Denmark. We support the global organization, therefore some travel should be expected (on average around 10 days per year). Qualifications As a person, you are proactive, courageous and have strong communication and interpersonal skills. You are organised, quality-conscious, and detail-oriented without losing the big picture. You are a team player, and you thrive working across departments in an international organisation. Not least, you are flexible by nature and can see yourself thriving with a schedule that can be difficult to predict, supporting various time zones. From an ideal candidate, we expect:
  • Academic degree in pharmacy, medicine, science, or similar
  • Minimum of 5 years of experience in clinical research and drug development
  • Solid knowledge of GCP and other relevant regulations
  • Track record within clinical quality assurance and/or trial management and within Clinical Inspections and/or GCP audits
  • Strong command of written and spoken English
    • Finally, you have a strong ability to keep calm under pressure and can work with people around you to spread that calmness. Working at [xxxxx] [xxxxx] 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 [xxxxx] is working toward something bigger than ourselves, and it’s a collective effort. [xxxxx] relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Pia Pamperin at [xxxxx] Deadline 14 April 2024. We will be screening, interviewing, and hiring on an ongoing basis. Please either write a short cover letter with your motivation for applying for this job or add this to your CV prior to applying. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] 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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    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 18.3.2024, men kan have været deaktiveret og genaktiveret igen.

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