Senior QMS Professional

Found in: beBee jobs DK - 1 week ago


Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS - A1p Full time
The position In Drug Product & Analytical Development Project Office, we are responsible for the analytical and drug product development for both early and late phase clinical trials, submission and much more. You will be a part of a small but growing group of skilled individuals, working to support 20+ analytical project managers. You will be the first with QMS experience, as primary skillset, and you will get the opportunity to impact our way of working with QMS processes. It will be your responsibility to support our analytical project managers on various GMP and documentation related tasks to ensure that the required product quality is achieved and consequently secure the safety of our patients.

You will:
Implement change requests, e.
G. For new/updated product specifications. Handle quality related tasks, such as SOP reviews/updates. Take part in CMO collaborations incl. Site audits/visits and document flow management. Collaborate with colleagues from other parts of CMC and manufacturing development, quality assurance and regulatory affairs. Take part in/lead standardising and optimising above mentioned tasks/processes. Furthermore, and depending on your qualifications and motivation, you are likely to be involved in regulatory documentation processes.

Here assignments could include:

write and review regulatory submission documents such as CTA (Clinical Trial Applications) and marketing applications related to the analytical field.

take part in the process of answering questions from health authorities across the globe related to our submissions. take part in giving content to the way we write our regulatory documents based on continuous learnings and feedback.

To succeed in this role, you will take ownership and have a proactive approach and close cooperation with colleagues in the Project Office and analytical departments, ensure that our setup and documentation is in order and that required product quality and compliance is achieved.

Qualifications We are currently looking for a colleague with experience from a quality related position, ideally combined with analytical development, as well as a Master's degree within Pharmacy, Chemistry, Engineering, or a similar field.

To be successful in this role, the following qualifications are relevant:
Strong knowledge and experience in quality management systems from pharmaceutical industry. Experience in writing and driving change request with many stakeholders. Familiarity with auditing, monitoring, and determining the quality of processes. Excellent attention to detail and ability to identify recurring problems. Good communication and collaboration skills. Experience with documents such as Justification of specification and product specifications. You have a structured and detail-oriented approach to everything you do.

You take pride in delivering high quality documents and to do so you build and create a network to improve your knowledge and skills.

On a personal note, you are open-minded, enjoy sparring and great colleagueship.

The department As part of Novo Nordisk PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world.

We develop, manufacture and distribute drug candidates for clinical trials and have a strong culture with a "can do" mind-set.

Your new department, CMC Drug Product Development
  • Project Office, consists of 50 employees located in Måløv.
The department is involved in early and late-stage drug product development, analytical development and chemical and biological characterization of new entities moving through the clinical phases of drug product development. Working at Novo Nordisk At Novo Nordisk, we don't wait for change. We drive it.

We're 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 embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them.

From research and development, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.


  • Senior IT Business Consultant

    Found in: beBee jobs DK - 2 weeks ago


    Ballerup, Ballerup Kommune, Denmark Ambu AS Full time

    Country: DenmarkLocation: Ballerup, DKCity: BallerupBusiness Area: ITEmployment type: Full-timeDo you want to play a central role in accelerating growth in a company that makes a difference for millions of patients and healthcare professionals every year, and continues to be at the frontier of innovation? Are you proactive and passionate about driving...

  • Senior Director, Head of Clinical Science and Toxicology

    Found in: beBee jobs DK - 2 weeks ago


    Ballerup, Ballerup Kommune, Denmark LEO Pharma AS Full time

    Field of work: Clinical DevelopmentPosting Date: 26 Mar 2024Application deadline: 15-April-2024 Location: Ballerup 2750, , Denmark Contract type: Permanent Job ID: 2027Role DescriptionAre you ready to take on a key leadership role in a global pharmaceutical company? LEO Pharma is seeking a dynamic and experienced Head of Clinical Science and Toxicology to...

  • Senior Software Developer

    Found in: beBee jobs DK - 4 days ago


    Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

    We are looking for a Senior Software Developer to join the R&D department - the beating heart of GN Audio. It's here that state-of-the-art Jabra communication and music products are born.Developing and maintaining GN Audio's software platforms for current and future products will be your mission. Ultimately, you will make life sound better through enterprise...

  • Finance Business Partner

    Found in: beBee jobs DK - 3 weeks ago


    Ballerup, Ballerup Kommune, Denmark Ambu AS Full time

    Country: DenmarkLocation: Ballerup, DKCity: Ballerup, DenmarkBusiness Area: FinanceEmployment type: Full-timeAre you passionate about analyzing data to enable informed decisions? Would you like to play a key role partnering with leaders within Global Operations in driving profitable growth and operations? And would you like to join a successful global...

  • Intern - R&D Secure Power

    Found in: beBee jobs DK - 2 days ago


    Ballerup, Ballerup Kommune, Denmark Schneider Electric Full time

    Job DescriptionWe are looking for 4 to 6 passionate Engineering Interns for multiple positions and within the different R&D engineering disciplines listed below. The Internships are focused directly on your education, and your professional and personal development.Would you like to be an intern with a company leading in Power Electronics, Embedded Control,...

  • Commercial Leader for Spacelogic

    Found in: beBee jobs DK - 2 days ago


    Ballerup, Ballerup Kommune, Denmark Schneider Electric Full time

    We are seeking a dynamic and results-oriented Commercial Leader to join our Hub organization and serve as the primary business interface between Hub & Global Commercial and front offices Leader. In this role, you will be responsible for advocating market needs, structuring, and ensuring the execution of commercial excellence strategy for Mid-market business...

  • Professor in Product Development

    Found in: beBee jobs DK - 3 weeks ago


    Ballerup, Ballerup Kommune, Denmark Technical University of Denmark Full time

    If you are passionate about creating impact for society, and want to be at the forefront of university-industry collaboration, and if you are you an experienced academic leader looking for a challenging senior leadership position, this may be the position to fulfil your dreams and ambitions. We seek to appoint a new Professor in the field of Product...

  • Firmware Test Engineer

    Found in: beBee jobs DK - 3 weeks ago


    Ballerup, Ballerup Kommune, Denmark Schneider Electric Full time

    Firmware Test Engineer We are in search of a proactive and skilled Test Engineer to join our Firmware development team and collaborate with the firmware development team in testing Firmware engineering test, with a focus on core control systems. This role involves conducting complex tests, participating in test means modifications, and test analysis in our...

  • Softwareudvikler til verdens førende e-sportsmedie

    Found in: beBee jobs DK - 3 weeks ago


    Ballerup, Ballerup Kommune, Denmark Bloom Full time

    Softwareudvikler til verdens førende e-sportsmedieHvis du har lyst til at spille en vigtig rolle i softwareudvikling af verdens største websites med Counter-Strike og FIFA, da læs endelig videre her. Vores kunde , ejet af Better Collective, er verdens største e-sportsmedie med fokus på både Counter-Strike, Dust2 og De har udviklet og driver et top...

  • Senior Quality System Specialist

    Found in: Talent DK C2 - 5 days ago


    Ballerup, Denmark Ambu Full time

    Do you have a true passion for QA business partnering? Do you want to be the corporate process owner of the global QMS processes for Change Control? Are you driven by aligning and setting direction?  Then this might be your defining moment. Apply today and join us for a career #ForeverForward!  A global job with impact  We are looking for a...

  • Senior IT Quality Professional

    Found in: Talent DK C2 - 2 weeks ago


    Ballerup, Denmark Novo Nordisk Full time

    The position requires significant insight into quality processes like audit, deviation handling, validation, CAPA, change control, records management, data integrity, as well as insights into Good Manufacturing Practice (GMP), including solid working knowledge from within manufacturing and or working with infrastructure services for intended use....

  • (Senior) FP&A Analyst

    Found in: Talent DK C2 - 2 weeks ago


    Ballerup, Denmark Ambu Full time

    Would you like to drive improvement and execution on the annual financial planning cycle? Do you carry strong analytical skills? Do you have experience in communicating business performance across management?  Then this might be your defining moment. Join us as (Senior) FP&A Analyst and drive your career #ForeverForward!  Key responsibilities  In...

  • Senior Scrum Master

    Found in: Talent DK C2 - 3 days ago


    Ballerup, Denmark Novo Nordisk AS Full time

    Are you an experienced & skilled Scrum Master who wants to help us drive the digital transformation of Novo Nordisk? Would you like to be part of an agile core team for Novo Nordisk Global IT Operations (GITO) and help us succeed with a continuous ambitious agile transformation of our Global IT Operations area? We are on an exciting digital journey, so we...

  • Senior CDMO Procurement Manager

    Found in: beBee S DK - 3 weeks ago


    Ballerup, Denmark Leo Pharma AS Full time

    Your role   As a Senior CDMO Procurement Manager, you will play a crucial role in managing all procurement activities related to our portfolio of Contract Development and Manufacturing Organizations (CDMOs). Being responsible for partners in the late stages of development across the spectrum to partners contracted for commercial production you’ll be...

  • Senior CDMO Procurement Manager

    Found in: Talent DK C2 - 3 weeks ago


    Ballerup, Denmark LEO Pharma Full time

    Your role   As a Senior CDMO Procurement Manager, you will play a crucial role in managing all procurement activities related to our portfolio of Contract Development and Manufacturing Organizations (CDMOs). Being responsible for partners in the late stages of development across the spectrum to partners contracted for commercial production you’ll be...


  • Ballerup, Denmark Leo Pharma AS Full time

    Your role :     As the Head of Clinical Science and Toxicology, your main objective will be to deliver input to business and functional strategies and translate the corporate business strategy into short to medium-term tactical direction. You will provide operational oversight, specify new processes and standards, and drive the business and functional...


  • Ballerup, Denmark Leo Pharma AS Full time

    Your role :     As the Head of Clinical Science and Toxicology, your main objective will be to deliver input to business and functional strategies and translate the corporate business strategy into short to medium-term tactical direction. You will provide operational oversight, specify new processes and standards, and drive the business and functional...

  • Senior Director, Head of Clinical Science and Toxicology

    Found in: Talent DK C2 - 3 weeks ago


    Ballerup, Denmark LEO Pharma Full time

    Your role :     As the Head of Clinical Science and Toxicology, your main objective will be to deliver input to business and functional strategies and translate the corporate business strategy into short to medium-term tactical direction. You will provide operational oversight, specify new processes and standards, and drive the business and functional...

  • Senior Finance Business Partner

    Found in: beBee S DK - 7 days ago


    Ballerup, Denmark Ambu AS Full time

    Country: DenmarkLocation: Ballerup, DKCity: Ballerup, DenmarkBusiness Area: FinanceEmployment type: Full-timeAre you passionate about analyzing data to enable informed decisions? Would you like to play a key role partnering with leaders within Global Operations in driving profitable growth and operations? And would you like to join a successful global...

  • Senior Business and Portfolio Lead

    Found in: Talent DK C2 - 1 week ago


    Ballerup, Denmark Novo Nordisk AS Full time

    Are you passionate about shaping the future of healthcare? Do you possess extensive experience in project portfolio management, adept stakeholder engagement, and a relentless pursuit of process excellence? If so, we invite you to join us as our new Senior Business and Portfolio Lead. Step into a pivotal role within our dynamic department and let's propel...

  • SAP SD/FI Specialist

    Found in: beBee S DK - 3 weeks ago


    Ballerup, Denmark Novo Nordisk AS - Lp42 Full time

    Would you like to support the development of Novo Nordisk’s Order to Cash (O2C) process and be part of deployment across our sales affiliate? Are you seeking an opportunity to define and implement IT solutions and engage with stakeholders across IT, Finance, and the Supply Chain Organisation in a truly international company?  Is it your profile we...

  • SAP SD/FI Specialist

    Found in: beBee S DK - 3 weeks ago


    Ballerup, Denmark Novo Nordisk AS - Lp42 Full time

    Would you like to support the development of Novo Nordisk’s Order to Cash (O2C) process and be part of deployment across our sales affiliate? Are you seeking an opportunity to define and implement IT solutions and engage with stakeholders across IT, Finance, and the Supply Chain Organisation in a truly international company?  Is it your profile we...

  • Senior PAM Architect

    Found in: Talent DK C2 - 5 days ago


    Ballerup, Denmark Novo Nordisk Full time

    The job is located in Ballerup, Denmark with travel activity of max 30 days per year. Candidate profile Senior PAM expert with a proven track record of driving PAM implementations in complex organizations, preferred in pharmaceutical or other regulated environments. Demonstrated ability to think strategically and collaborate effectively with...

  • Senior Finance Analyst, Strategic Key Accounts Finance

    Found in: beBee S DK - 4 weeks ago


    Ballerup, Denmark Gn Hearing AS Full time

    Join GN Hearing’s Finance team to drive our largest global customers & business development opportunities Would you like to get exposed to all aspects within business finance and be part of an ambitious team as our new Senior Finance Analyst? We are looking for a passionate and dedicated team member who want to develop and to take part in driving...

  • Senior Finance Manager, GN Group

    Found in: beBee S DK - 4 weeks ago


    Ballerup, Denmark Gn Hearing AS Full time

    Do you want to make your financial knowledge count? Imagine a possibility where you will be responsible for financial excellence by supporting and further developing the finance function in a global organization. We encourage all qualified applicants to apply regardless of age, gender, religion, country of origin or ethnicity. As a Senior Finance...

  • Senior Finance Manager, GN Group

    Found in: beBee S DK - 3 weeks ago


    Ballerup, Denmark Gn Hearing AS Full time

    Do you want to make your financial knowledge count? Imagine a possibility where you will be responsible for financial excellence by supporting and further developing the finance function in a global organization. We encourage all qualified applicants to apply regardless of age, gender, religion, country of origin or ethnicity. As a Senior Finance...

  • Senior Business and Portfolio Lead

    Found in: Talent DK C2 - 1 week ago


    Ballerup, Denmark Novo Nordisk Full time

       Are you passionate about shaping the future of healthcare? Do you possess extensive experience in project portfolio management, adept stakeholder engagement, and a relentless pursuit of process excellence? If so, we invite you to join us as our new Senior Business and Portfolio Lead. Step into a pivotal role within our dynamic department and let's...

  • Senior Software Developer

    Found in: Talent DK C2 - 3 weeks ago


    Ballerup, Denmark GN Group Full time

    We are looking for a Senior Software Developer to join the R&D department - the beating heart of GN Audio. It’s here that state-of-the-art Jabra communication and music products are born. Developing and maintaining GN Audio's software platforms for current and future products will be your mission. Ultimately, you will make life sound better through...

  • Associate Global Pricing Manager

    Found in: Talent DK C2 - 5 days ago


    Ballerup, Denmark Ambu Full time

    Ambu A/S is currently looking for a Global Associate Pricing Manager. As Associate Global Pricing Manager for Ambu, you will play a critical role in developing and implementing pricing strategies to maximize profitability and market competitiveness. You will collaborate with cross functional teams, analyse market trends, and leverage data driven insights...