Principal Quality Assurance Specialist

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Gentofte

Are you experienced in conducting clinical trials within a Phase I unit? Then read more as this could be a perfect opportunity for you! Come join us and help build our new phase 1 unit CLINiC (Clinical Innovation Centre). The position In this role you will report to the Head of CLINiC and be responsible for leading CLINiC’s Quality Compliance activities. You will work closely with colleagues across skill types and areas within CLINiC, as well as colleagues from Novo Nordisk’s Quality function and lead the identification and setting of CLINiC quality objectives/targets and ensure progress is known. You will use your knowledge of GCP (Good Clinical Practice) and phase I clinical trials to review and approve SOPs (Standard Operating Procedures), as well as performing compliance checks across CLINiC processes. Furthermore, you will take the lead facilitating internal audits and inspections from the Health Authorities. Among your daily tasks, you will:
  • Speak, educate, and engage your CLINiC colleagues in a way that supports a continuous and thriving quality culture
  • Take lead on quality compliance activities
  • Support structured risk management activities
  • Perform audit of required GCP quality documents
  • Conduct training in relevant processes and legislation
    • You will also support equipment maintenance, calibrations, expiry management and secure Quality oversight. As part of your audit routines, you will review and approve deviations, Change Requests and CAPAs supporting the trials. Qualifications To succeed in this role, you can recognize yourself in the following:
  • You have experience working within phase 1 clinical research which enables you to work independently, set directions and deliver results
  • Solid knowledge of GCP
  • Expertise in applicable quality standards and pharmaceutical process and value chain understanding
  • Strong communication skills in written and spoken English
    • As a person, you have a strong sense of detail, a quality mindset, and the ability to navigate complexity, provide direction and assess compliance. You thrive in a changing and dynamic work environment and have a can-do attitude with the ability to prioritize, execute and follow up in a proactive and timely manner. You are a team player and a strong collaborator across the organization. About the department You will become part of our CLINiC Quality department located in Gentofte, Denmark. The CLINiC is currently under development and will be responsible for conducting multiple clinical pharmacology trials with trials of an explorative nature, ultimately conducting First Human Dose studies. The CLINiC works closely with various partners within Novo Nordisk as well as externally across the Danish life science ecosystem. The CLINiC is part of Global Translation, where we drive all clinical development of products from early development phases to product introduction and life cycle management. Historically, all Novo Nordisk phase 1 trials have been outsourced to CROs. Looking into the future with Novo Nordisk entering new therapeutic areas, there are increased requirements for agility and early decision-making and a need to complement the current set-up with new options for early phase and exploratory development. 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 to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For further information, contact Roland Foster Head of Digital & Quality at +45-30752817. Deadline 10 September 2023. We call for interviews on an ongoing basis and close the position as soon as we find the right candidate. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Gentofte.

    Jobbet er oprettet på vores service den 31.5.2023, men kan have været deaktiveret og genaktiveret igen.

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