Quality Assurance Specialist

1 month ago


Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time
Job Title: QA Project Specialist

Are you passionate about ensuring the highest quality standards in pharmaceutical manufacturing? Do you have a strong background in quality assurance and a desire to work in a dynamic and international environment?

We are seeking a highly skilled QA Project Specialist to join our team at Novo Nordisk. As a QA Project Specialist, you will be responsible for ensuring the quality and compliance of our pharmaceutical products, working closely with our Contract Manufacturer Organizations (CMOs) and internal stakeholders.

Main Responsibilities:
  • Quality responsibility for technical transfers to CMOs, ensuring compliance with GMP requirements
  • Leading the implementation of quality agreements and process validation strategies
  • Collaborating with CMOs to promote good quality practices and compliance culture
  • Negotiating and implementing quality agreements, approving process validation strategy and related documents
  • Setting up QA processes for commercial manufacturing
  • Participating in qualification audits and ensuring follow-up on CAPAs

You will also be responsible for managing quality issues during technical transfers, including process validation documentation, deviations, out-of-specifications, change controls, action plans, and follow-up. Additionally, you will evaluate production documentation and ensure compliance with regulatory requirements.

Requirements:
  • Academic degree in Pharmacy, Engineering, or a related field
  • Minimum 5 years of experience in the pharmaceutical industry, either in production or QA
  • Strong knowledge of quality and GMP requirements, with the ability to take decisions on quality representing Novo Nordisk
  • Proficient in English, with knowledge of other languages an advantage

We offer a dynamic and international work environment, with opportunities for professional and personal development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.



  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk. In this role, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesDevelop and implement quality assurance strategies to ensure compliance with regulatory requirementsConduct audits and...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled and experienced Quality Assurance professional to join our team at Novo Nordisk. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the quality of our Contract Manufacturing operations and providing QA support to our global CMOs.Key ResponsibilitiesEnsure compliance with cGMP and...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job SummaryWe are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Novo Nordisk. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the quality of our products manufactured by Contract Manufacturing Organizations (CMOs) worldwide.Key ResponsibilitiesEnsure compliance with cGMP and Marketing...


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

    Job Title: QA Project SpecialistAre you passionate about ensuring the highest quality standards in pharmaceutical production? Do you have a strong background in quality assurance and a desire to work in a dynamic and international environment?We are seeking a highly skilled QA Project Specialist to join our team at Novo Nordisk A/S. As a QA Project...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job DescriptionWe are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Novo Nordisk. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the quality of our products manufactured by Contract Manufacturing Organizations (CMOs) worldwide.Key Responsibilities:Ensure compliance with cGMP and...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleAs a Quality Assurance Specialist in our Global Contract Manufacturing (GCM) QA team, you will play a critical role in ensuring the quality and compliance of our outsourced production activities worldwide.Main ResponsibilitiesProvide quality assurance and quality support to outsourced production activities worldwide.Deliver QA support and set...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    We're seeking a highly skilled Senior Quality Assurance Specialist to join our team at Novo Nordisk Global Contract Manufacturing (GCM) QA. As a key player in ensuring regulatory compliance and product quality, you'll have the opportunity to make a real impact on our company's success.The ideal candidate will have a strong background in quality assurance and...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job DescriptionWe are seeking a highly skilled GCP Quality Assurance Specialist to join our team at Novo Nordisk.About the RoleThis is an exciting opportunity to work in a dynamic area where you will take ownership and responsibility for setting the right quality level in the global organisation. As a GCP Quality Assurance Specialist, you will be part of a...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job Title: Quality Assurance Specialist in Assembly and PackagingAre you passionate about ensuring the highest quality standards in pharmaceutical manufacturing? Do you have a strong background in quality assurance and a keen eye for detail? We are seeking a highly skilled Quality Assurance Specialist in Assembly and Packaging to join our team at Novo...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk. As a QA Project Lead, you will be responsible for ensuring the quality and compliance of our contract manufacturing operations worldwide.Main ResponsibilitiesQuality responsibility for the technical transfer to the CMOs in market and capacity...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job Title: QA Project Specialist LCMOWe are seeking a highly skilled and experienced QA Project Specialist to join our Global Contract Manufacturing (GCM) QA team at Novo Nordisk. As a QA Project Specialist, you will be responsible for ensuring the quality and compliance of our outsourced production activities worldwide.Main Responsibilities:Quality...


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

    Job Title: QA Project SpecialistAre you passionate about ensuring quality and compliance in a global network of Contract Manufacturer Organizations (CMOs)? Do you have a strong background in quality assurance and a desire to make a positive impact every day?About the RoleIn this exciting role, you will be the QA representative in project transfers from Novo...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Join Our Team as a QA Specialist in Assembly and PackagingWe are seeking a highly skilled QA Specialist to join our team in assembly and packaging. As a QA Specialist, you will play a pivotal role in ensuring the quality and compliance of our products.Main Responsibilities:Provide GMP direction to QA colleagues and outsourced production teamsSupport the...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Join Our Team as a QA Specialist in Assembly and PackagingAbout the RoleWe are seeking a highly skilled QA Specialist to join our team in assembly and packaging. As a QA Specialist, you will play a pivotal role in ensuring the quality and compliance of our products. Your extensive QA and GMP knowledge will be leveraged to ensure product quality and...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Novo Nordisk. In this role, you will be responsible for ensuring the quality of our products manufactured through contract manufacturing organizations (CMOs).Key Responsibilities:Ensure compliance with cGMP and marketing authorization requirementsCollaborate...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job Title: QA Project Specialist LCMOAbout the Role:In this exciting position, you will be responsible for ensuring the quality and compliance of our contract manufacturing operations worldwide. As a QA Project Specialist, you will work closely with our global CMOs to ensure that they meet our quality and regulatory requirements.Main Responsibilities:Quality...


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

    We are seeking a highly skilled Pharmaceutical Quality Assurance Specialist to join our team at Novo Nordisk Global Contract Manufacturing (GCM) QA.The successful candidate will play a key role in ensuring the safety, efficacy, and compliance of our contract manufacturing for drug product Contract Manufacturing Organizations (CMOs).Main tasks will...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job Title: QA Project Specialist LCMOAbout the Role:We are seeking a highly skilled and experienced QA Project Specialist to join our Global Contract Manufacturing (GCM) QA team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our outsourced production activities worldwide.Key Responsibilities:Provide QA...


  • Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

    Job SummaryWe are seeking a skilled Quality Assurance Specialist to join our Global Contract Manufacturing (GCM) QA team. As a QA Project Specialist LCMO, you will be responsible for ensuring the quality and compliance of our contract manufacturing operations worldwide.Key ResponsibilitiesQuality responsibility for the technical transfer to CMOs in market...


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

    As a Quality Assurance Specialist at Novo Nordisk A/S, you will play a critical role in ensuring the safety, efficacy, and compliance of our contract manufacturing for drug product Contract Manufacturing Organizations (CMOs) in our QA Aseptic (AP) Operation team.Main tasks will be to:ensure that all manufacturing activities adhere to relevant regulations and...