Quality Specialist

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Søborg

Are you the go-to Good Manufacturing Practice specialist in your area and are you ready to use your process optimisation skills and quality mindset in a highly professional and engaged global environment? Are you passionate about quality and simplicity and eager to drive into an emerging area, with the opportunity to shape its growth and leave a meaningful mark? Then join us, as our new Quality Specialist and be a part of our expanding team! Don't miss this opportunity—submit your application today! The position The Quality Specialist position is in the Quality Department for Global Safety (GS) & Regulatory Affairs (RA) based in Søborg, Denmark. Here we support the GS and RA areas in many aspects of quality and there is now a stronger need for support in integration activities of future partnerships and acquisitions. As a Quality Specialist, your core responsibilities will include:
  • Ensuring a smooth and well integration process of the acquired assets into our organisation and within the QMS, Pharmacovigilance, and Regulatory processes
  • Supporting in the assessment of new changes, new requirements, new therapeutic areas, drug-device-software combination, IVD, stem cells, etc
  • Appling Quality expertise to mitigate process gaps and improve processes, and to be the quality partner offering QMS support and guidance to our stakeholders
  • Quality Assurance for Deviations, Change requests, SOPs, Inspections and audits
  • Leading and managing quality process improvements and being the enabler for new complex circumstances in GS and RA areas
  • Facilitate workshops, share knowledge within the department and across R&D Quality, to engage the organisation by building 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 within quality assurance or quality management processes with extensive experience with quality requirements (GxP), ISO13485, and other relevant regulations
  • Prior experience within Pharmacovigilance or Regulatory processes like submission, registration, and labelling, 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 is one of three sister departments in Research and Development Quality Operation, which is part of R&D Quality in [xxxxx]. We are a very diverse quality department that supports a large organization and with global stakeholder interaction. In GS & RA Quality we offer Quality Management System expertise for our stakeholders and play a vital role in ensuring high-quality fit-for-purpose processes throughout the value chain. As we also take an active part in cross-organisational improvement projects and provide general quality and compliance support to our global organisation, we are on an exciting journey bringing quality to the top of the agenda throughout the organisation for the benefit of our patients. Working at [xxxxx] 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 [xxxxx], 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. Contact For further information, please contact Lavinia M. Pedersen at +[xxxxx]. Deadline 1 April 2024. 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 6.3.2024, men kan have været deaktiveret og genaktiveret igen.

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    • Øvrige
    • Søborg
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