Senior Project Manager for Validation of Finished Product Processes

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Hillerød

Are you a seasoned project manager ready for an exciting opportunity? Do you thrive collaborating in a dynamic environment and are committed to delivering stellar results? If so, this is you moment. Join us in Device Manufacturing Development (DMD) Assembly & Packaging (A&P) Strategic Support, a team where your impact matters. Seize the chance and apply today! The position The role of Senior Project Manager for Validation of Finish Product processes in A&P involves close collaboration with manufacturing organizations in [xxxxx] as well a large portfolio of project teams in DMD. Your primary responsibility is to drive the project quality strategy for establishing and deploying standardized process validation for A&P. Your key tasks entail:
  • Coordinating the planning of documents and procedures to support standardization
  • Ensuring documents and templates build on NN validation process from Science- and Risk-based approach to validation are aligned with Fill & Finish Expansion (FFEx) Quality strategy
  • Driving the implementation of clear roles and responsibilities and coordinating training and implementation across programs and projects
  • Collaborating with internal program organisation FFEx and specialists
  • Partnering with validation experts to develop modern approaches to validation that ensure harmonization and simplification across A&P
  • Communicating effectively with stakeholders at all levels to ensure alignment and transparency
  • Qualifications To be successful in this role, we believe you:
  • Hold at least a bachelor’s degree in pharmacy, Engineering, Supply Chain, Project Management, or a related field
  • Showcase proven experience working with process validation experts as a project manager in a pharmaceutical manufacturing environment
  • Demonstrate knowledge of external regulations for aseptic products, medical devices and finished products e.g. as anchored in the [xxxxx] Quality Management System
  • Bring expertise in process validation and regulatory compliance
  • Display proficiency in both spoken and written English
  • Experience working with external partners and management experience are preferred. As a person, you possess exceptional communication skills, are adept at negotiation, and seamlessly connect with stakeholders. You excel in navigating diverse perspective and orchestrating decisions that align with the best interest of everyone involved. You are not just a team player but also an inspiration, transforming challenging into opportunities for the team’s and business’ success. About the department You will join DMD and the A&P Strategic Support team, a key function supporting assembly and packaging of Novo Nordisk finished products, primarily pen injectors and tablets. We are bridging product development to production and driving development and standardization of new, smarter and aligned processes. Furthermore, we are responsible for establishing assembly and packaging capacity worldwide for new and marketed products in compliance with current regulatory requirements and in close interaction with the [xxxxx] global production sites. We have an end-to-end presence from device development to production implementation and support to running production. We are located in Hillerød and are a department that is growing rapidly, consisting of over 150 employees placed into different teams. At the office, we share an informal tone, great work morale and tall ambitions to be the best at what we do. Once you step into this role, you will join a diligent and highly competent team and be at the crossroad between Device and Delivery Solutions, Quality, and Production. 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 energise 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 Senior Manager, Hans Kristian Rømer Westh, at +[xxxxx]. Deadline 18 April 2024. Please note that applications will be reviewed on an ongoing basis. Therefore, 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 why you are applying in your resume or CV. 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.


    Information og data

    Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 22.2.2024, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 04.04.2024
    • Projektleder
    • Hillerød

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