Senior CVP GMP Partner

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Kalundborg

Are you ready to play a crucial role in ensuring that IFP Kalundborg (IFP KA) stays in compliance with both internal and external regulatory requirements ? Do you want to unfold your comprehensive knowledge about GMP and continuous improvement and take it to the next level? Are you self-motivated, structured and have an efficient nature, and the ability to see solutions in a broader perspective? Then you might be the candidate we are looking for! About the Department The team is part of the Injectable Finished Products (IFP) where we in Kalundborg are app. 450 colleagues taking responsibility for delivering finished products that patients can use all over the world. We bring value to patients by delivering high-quality Good Manufacturing Process (GMP) compliant products in a timely and cost-efficient manner. We drive change by working actively with cLEAN and always look to improve our processes, and we prioritize close collaboration. The Position As our new CVP GMP Partner you ensure a high level of quality and compliance in our Assembly & Packaging facility in Kalundborg and ensure that the department continuously delivers on all relevant GMP requirements, including proactively improving quality mindset in the organization . You will work closely with both management and other stakeholders in the department and across departments, including QA. You will also host and act as a key person by representing IFP KA in audits and inspections as well as QMT investigation responsible. The scope of tasks in this role covers, but not limited to:
  • Define GMP Strategy for our site in collaboration with relevant stakeholders.
  • Coach managers on all levels in IFP KA regarding quality and compliance
  • Train the organisation in GMP and act as local DV expert in IFP KA
  • Host audits and inspections.
  • Represent CVP in IFP KA compliance projects and initiatives when necessary.
  • Support Science and Risk based Validation processes and drive deviation reduction.
  • Secure input to relevant authority applications and filings in IFP KA
  • Identify quality improving initiatives and involve relevant parties in plans and execution.
  • Secure License to operate in close corporation with QP Kalundborg
  • Contribute to site management processes when needed.
    • Qualifications To succeed in this role, you:
  • Have a master’s degree in sciences such as pharmacy, biochemistry, or production engineering or similar .
  • Have 8+ years of experience with QMS, audits and inspections within pharma.
  • Exhibit proficiency in collaborating with a diverse range of stakeholders.
  • Solid experience with GMP, compliance and documentation
  • Full proficiency in both English and Danish.
  • Have the ability to build and leverage relations across areas and levels.
  • Have experience in functional management coupled with a comprehensive understanding of corporate dynamics.
  • Possess innate authority and aren’t fazed by delivering difficult messages or spearheading inconvienient changes.
  • Showcase fluency in both written and spoken English.
    • On a personal level, you are motivated by working with and across all levels in the organisation, whilst you are known for your excellent collaboration and communication skills and ability to set direction. You are solution oriented and work systematically, proactively and strive for simplicity in processes. Working at Novo Nordisk At Novo Nordisk, we do not wait for change. We drive it. We are 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 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 To learn more about this opportunity please call, Corporate Vice President, Gerrit Liebgen +45-34483354 Deadline December 1st 2023. Interviews will be held throughout the period, and we encourage you to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation in your 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 Kalundborg.

    Jobbet er oprettet på vores service den 6.11.2023, 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
    • Kalundborg
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