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Søborg

    Quality Specialist - Søborg, Danmark - Novo Nordisk

    Novo Nordisk
    Novo Nordisk Søborg, Danmark

    for 6 dage siden

    Novo Nordisk background
    Beskrivelse
    The position

    The Quality Specialist position is part of the Quality Department for Global Safety (GS) & Regulatory Affairs (RA) located in Søborg, Denmark.

    We provide quality assistance to our Safety and Regulatory colleagues in various aspects, and we need more help with Pharmacovigilance inspections and with merging future acquisitions and partnerships.

    As a Quality Specialist, your core responsibilities will be:
    Quality Assurance for Deviations, Change requests, SOPs, and especially for the Pharmacovigilance Inspection findings and audits.

    Helping in the evaluation of new changes, new requirements, new therapeutic areas and products Leading and managing quality process improvements and enabling new complex situations in Safety areas Making sure that the acquired assets are well integrated into our organization and within the QMS, Pharmacovigilance, and Regulatory processes Using Quality expertise to address process gaps and improve processes, and to be the quality partner providing QMS support and guidance to our stakeholders Conduct workshops, share knowledge within the department and across R&D Quality, to involve the organisation by creating the right level of compliance, readiness, and ownership around the optimisations to come.

    The role entails taking responsibility for shaping and optimising the framework for the quality role during integrations.

    In this position, you may also be involved in other activities in the department such as improvement, optimisation and digitalization of quality processes, the way we work as QAs, and the use of data for QA oversight.

    You will be part of a dynamic area, where the position offers high impact, and where you are expected to take ownership and responsibility for setting the right quality level in the global organisation.

    Qualifications As a person you approach problem-solving with a positive and practical mindset, always seeking opportunities to optimise and simplify processes.

    Your proactive and courageous nature is complemented by your excellent communication and interpersonal abilities.

    We're looking for candidates who bring these qualifications:

    A master's degree in science, pharmacy, biology, or similar A minimum of 6+ years of working experience in Quality Assurance or quality management processes within pharmaceutical companies Extensive experience with quality requirements (GxP), ISO, quality management systems and other relevant regulations Prior experience within Pharmacovigilance processes is preferable Preferred qualifications include experience in integration processes, project management and/or cLEAN (continuous improvement) Proficiency in both written and spoken English.

    Additionally, you possess a strong sense of organisation and attention to detail without losing sight of the broader picture. Your commitment to quality is unwavering, and your innate curiosity drives your continuous learning.

    You excel as both a collaborative team member and an independent worker, thriving in cross-departmental collaborations within an international organisation.

    About the department Global Safety and Regulatory Affairs Quality (GS & RA Quality) is one of four related departments in Research and Development Quality Operation, which belongs to R&D Quality in Novo Nordisk.

    We are a quality department with a lot of diversity that supports a large organization and interacts with global stakeholders.

    In GS & RA Quality we provide Quality Management System expertise to our stakeholders and have a key role in ensuring high-quality processes that meet the needs throughout the value chain.

    We also participate in cross-organisational improvement projects and give general quality and compliance support to our global organisation, which means we are on an interesting journey to make quality a top priority throughout the organisation for the sake of our patients.

    Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities and challenges.

    For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research to our rich personal lives that motivate and energize us to perform our best at work.

    Ultimately, life is why we're all here - to ensure that people can lead a life independent of chronic disease.

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