Risk Manager for Primary Packaging Solutions

2 weeks ago


Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

About the Role

As a Risk Manager for Primary Packaging, you will play a crucial part in the Life Cycle Management (LCM) of Risk Management documentation packages related to Primary Packaging (PrimPack).

Working in close collaboration with R&D, Production, and Supply Chain, you will be responsible for reviewing and updating Risk Evaluation and Control Agreements when implementing new or modified Drug Products or combination products.

You will also oversee the process for transfer of the risk package to PrimPack Injectables and govern the process for LCM of PrimPack product risk documents, ensuring they are ready for periodical reviews.

Key Responsibilities

  • Review and update Risk Evaluation and Control Agreements for new or modified Drug Products or combination products
  • Oversee the process for transferring the risk package to PrimPack Injectables
  • Govern the process for LCM of PrimPack product risk documents
  • Ensure processes are compliant with internal and external requirements

Requirements

  • Master's degree or Ph.D. in engineering or a relevant field within the natural sciences
  • Experience working in a GMP environment with risk management tools and methodologies
  • Strong understanding of medical device regulations and standards
  • Proven track record of successfully managing risk within medical device development projects

About the Department

You will join the Material Manufacturing Development - Primary Packaging Department in Product Supply, Sourcing Operations, working at the company headquarters in Bagsværd, Copenhagen.

The department consists of approximately 50 employees, organized in 4 teams, and is responsible for implementing complex Primary Packaging materials and maintaining documentation on existing materials.

We cooperate with various functions, including CMC, Device R&D, QC laboratories, QA, and external suppliers and contract manufacturers (CMO).

Working at Novo Nordisk

We are a proud life-science company, 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.



  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a Chief Risk Officer for Primary Packaging to join our Material Manufacturing Development team in Product Supply, Sourcing Operations.As a key member of our team, you will be responsible for managing risk within medical device development projects from concept to commercialization. This includes reviewing and updating Risk...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Principal Quality Engineer to join our Primary Packaging team in Product Supply, Sourcing Operations. As a key member of our team, you will be responsible for developing, qualifying, and validating new equipment and test methods for primary packaging QC laboratory.


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Are you an authentic and empathetic people leader with a strong track record of leading teams in daily operations and through change?Do you have the ability to oversee team development and provide clear purpose?Do you have natural talent for collaboration and stakeholder management skills?This opportunity is perfect for someone who enjoys working closely...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Novo Nordisk A/SAt Novo Nordisk, we are committed to making a difference in the lives of people with diabetes and other serious chronic conditions. As a Senior Global Financial Risk Management Director, you will play a critical role in shaping our company's financial risk management strategy.About the RoleThis is an exceptional opportunity for a seasoned...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly motivated and experienced IT/OT Solution Manager to join our team. As a critical member of our CMC API Pilots organization, you will be responsible for designing, implementing, and managing IT/OT solutions to enhance operational efficiency, reliability, and security.Key ResponsibilitiesDevelop and maintain system...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job Description:The Category Manager - Renewable Energy will be responsible for sourcing global renewable energy solutions for Novo Nordisk's manufacturing sites. The ideal candidate will have a strong passion for renewable energy and the ability to show a commercial edge in sourcing.Key Responsibilities:Collaborate with line of business to address...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Position OverviewWe are seeking a highly skilled IT/OT Solution Manager to join our team at Novo Nordisk. The successful candidate will be responsible for designing, implementing, and managing IT/OT solutions to enhance operational efficiency, reliability, and security. A key aspect of the role will be bridging the gap between IT and OT systems, ensuring...

  • Project Manager

    15 hours ago


    Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job DescriptionAs a Project Manager - Portfolio Leader at Novo Nordisk, you will be part of our team responsible for overseeing a portfolio of investment projects. These projects focus on energy optimization, renovation, and life-time investments to ensure optimal facility conditions across our activities in Måløv.Your primary tasks will include:Managing...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job DescriptionOverviewAs a Test Engineer with Novo Nordisk, you will play a crucial role in developing, qualifying, and validating new equipment and test methods for the primary packaging QC laboratory. This position requires close collaboration with QC laboratories, as we do not have laboratory facilities in-house.Key ResponsibilitiesIdentify and procure...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Are you a strategic thinker with a passion for quality and process improvement? As a Quality Assurance Manager - Packaging at Novo Nordisk A/S, you will play a key role in ensuring the highest standards of quality in our packaging operations.Key ResponsibilitiesDevelop and implement quality strategies to drive continuous improvement in packaging...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    We are seeking a highly skilled H&S Strategist to join our Corporate Facilities team at Novo Nordisk A/S. This is an exciting opportunity for a professional with a strong background in Health and Safety (H&S) to drive strategic initiatives and collaborate across the organization.As an H&S Strategist, you will be responsible for driving the H&S agenda and...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About Novo NordiskNovo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases.Job DescriptionWe are seeking an experienced professional to join our Global Logistics & Distribution (GL&D) team as a Global Cold Chain Solutions Manager. As part of this role, you will be responsible for...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Are you an experienced project management professional seeking a challenging role in strategic sourcing?We are looking for a skilled Senior Category Project Lead to join our team at Novo Nordisk's Product Supply division, where you will be responsible for leading procurement projects related to M&A and pipeline activities.The successful candidate will have a...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the JobNovo Nordisk is seeking an experienced Renewable Energy Solutions Specialist to join our team. The successful candidate will be responsible for sourcing global renewable energy solutions to support our manufacturing sites worldwide.Key Responsibilities:Collaborate with line of business to address location-specific conditions and...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the OpportunityWe are seeking an experienced and results-driven Lead Supply Chain Manager to join our team at Novo Nordisk A/S.As a key member of our Inbound Supply Management department, you will play a crucial role in leading our packaging material supply planning operations. Your expertise will drive business growth, improve operational efficiency,...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About Novo Nordisk A/SNovo Nordisk A/S is a leading pharmaceutical company with a strong commitment to improving the lives of people around the world. Our products and services are designed to address some of the world's most pressing health challenges, including diabetes and chronic diseases.Salary: DKK 950,000 - DKK 1,300,000 per year (approximately...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job DescriptionWe are seeking a highly skilled Solution Architect with expertise in Global Payroll, Time & Attendance, and Shift Planning solutions to join our team at Novo Nordisk A/S.About the RoleIn this exciting opportunity, you will collaborate with global stakeholders to design comprehensive solutions for Global Payroll, Time & Attendance, and Shift...


  • Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Are you an experienced finance professional looking for a new challenge?We are seeking a highly skilled Director to join our Corporate Treasury team as the head of Global Financial Risk.As a key member of our management team, you will be responsible for mitigating financial risks across our global organisation, balancing these with business opportunities,...

  • Project Manager

    2 weeks ago


    Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job Title: Project ManagerOur department is seeking a skilled Project Manager to join our team at Novo Nordisk. As a Project Manager, you will be responsible for managing a portfolio of investment projects, including energy optimization projects, renovation, and life-cycle investments. Your primary tasks will be:Key Responsibilities:Project Management:...

  • IT Validation Manager

    2 weeks ago


    Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    We are seeking a skilled and motivated Lead IT Validation Manager to join our team at Novo Nordisk. The successful candidate will navigate a varied stakeholder landscape, driving continuous improvements of validation methods and setting the direction for the team in relation to validation best practices and compliance requirements.In this role, you will...