Laboratory QA for Devices & Delivery Solutions development

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Hillerød

Are you motivated by regulatory requirements, setting compliance direction and advising your colleagues across the organization? Are you a solution-oriented person with a passion for Quality Assurance? Do you get inspired by using quality as an active driver of securing testing of devices during development is performed in a compliant environment? If yes, then you might be the person we are looking for in Devices & Delivery Solutions Quality in Hillerød, Denmark. Apply now for our Quality Assurance Professional job opportunity focused on Quality Assurance and Oversight of Verification Laboratories. The position We are seeking a highly qualified candidate to support product development by providing quality oversight of test methods, equipment, and laboratories for the verification of devices in the development of Drug-Device Combination Products. As a Laboratory QA for Devices & Delivery Solutions, your key responsibilities will include:
  • Collaborating with various internal stakeholders within Novo Nordisk and external testing partners to ensure compliance and quality oversight.
  • Compliance advisory for laboratory operations, including testing equipment, methods, and IT systems in digitalized and automated laboratory processes.
  • QA review and approval of protocols and reports for equipment qualification and test method validation for design verification of Pen injectors.
  • QA oversight in metrology and validation activities in the verification laboratory.
  • QA review and approval of deviations in the verification laboratory.
  • Supporting continuous improvement and regulatory compliance for the processes owned by the verification laboratory.
    • Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace, blending home office and on-site work in Hillerød, Denmark. Qualifications
  • Hold a master’s degree within engineering, medicine and technology, pharmacy, chemistry or similar with a strong quality mindset.
  • Have experience with equipment qualification and test method validation, within Pharmaceutical or Medical Device industry.
  • Having worked with risk management according to ISO14971 is an advantage.
  • Fluent in both written and spoken English at a professional level.
    • On a personal level, you engage effectively with stakeholders, navigate complex situations with a solution-oriented approach. You must be able to quickly understand dilemmas, have a good overview, be a clear communicator with the use of facts and driven by ensuring regulatory compliance and patient safety. You independently apply your expertise, drive improvements, and is a team player who actively share knowledge. About the department Devices & Delivery Solutions Quality is accountable for covering all quality aspects in the development portfolio of primary packaging, mechanical devices, devices with embedded electronics and software, and software as a medical device, as well as projects investigating new paradigms for drug delivery. Further, we work on Quality Management System activities, quality oversight of our suppliers, and host inspections. We are an area of 33 passionate Quality Assurance experts split over 3 teams of which the vast majority is based in Hillerød, Denmark. Along with the rest of the device development area, we have a high focus on patients and take pride in having a significant impact on the life of patients by ensuring high quality, safe, and effective products. The QA Pen Injector variant and verification team consist of 10 QAs, who support the development of pen-injector variants and all testing laboratory activities related to Design verification. In the team we offer an open and honest work atmostphere with a great diversity among the team members. Working at [xxxxx] At [xxxxx], 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 If you have any questions about the job, please do not hesitate to call Vicki Gedye, Quality Senior Manager at +[xxxxx]. Deadline 23rd of March 2025. 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.


    Information og data

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

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 7.3.2025, men kan have været deaktiveret og genaktiveret igen.

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