Regulatory Expert in Pharmaceutical Quality Assurance

4 days ago


Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

Lundbeck A/S is a global pharmaceutical company dedicated to transforming lives through innovative treatments for brain disorders. As a leading developer of life-changing medicines, we strive to make a meaningful difference in the lives of people affected by these conditions.

As a Regulatory Expert in Pharmaceutical Quality Assurance, you will play a crucial role in ensuring patient safety and GMP compliance of Investigational Medicinal Products (IMP) for clinical trials. Your expertise will be essential in supporting the progression of our pipeline of promising drug candidates.

The ideal candidate will hold a master's degree in pharmacy, chemistry, biology, or a related field, with 1-2 years of experience in a GMP regulated environment in Manufacturing, Quality Control, or Quality Assurance. Sterile and biologic manufacturing knowledge is an advantage, as well as knowledge and experience within CMC.

You will collaborate with multiple stakeholders in CMC and contribute to the continued development of our processes. Our team has a great opportunity to impact current ways of working and streamline our processes.

We offer a unique position for you to build upon your experiences and professional development. The job offers great opportunities to grow your skills and knowledge and widen your tasks and responsibility as you develop in the role.



  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    About the JobAs a Senior Quality Assurance Professional at Novo Nordisk A/S, you will play a vital role in ensuring the quality of our raw materials and packaging materials. You will be responsible for collaborating with cross-functional teams to implement quality assurance processes and ensure compliance with regulatory requirements.The position offers a...


  • Copenhagen, Copenhagen, Denmark AGC Inc Full time

    We are looking for a talented Quality Assurance Expert to join our QA Mammalian team at AGC Inc. As a key member of the team, you will be responsible for ensuring the highest standards of quality and compliance with regulatory requirements.About the Role:Develop and implement quality assurance strategies to ensure compliance with regulatory...


  • Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    We are looking for a Pharmaceutical Industry Quality Leader to join our Quality Assurance department. As a key member of our team, you will be responsible for shaping and defining the future of our quality assurance processes.About the PositionThis is an exciting opportunity for someone who is passionate about quality assurance and has a strong background in...


  • Copenhagen, Copenhagen, Denmark AGC Inc Full time

    Regulatory Quality Assurance ManagerWe are seeking an experienced Regulatory Quality Assurance Manager to join our team in QC General Analytics. The successful candidate will have a strong background in regulatory affairs and experience in quality assurance, method validations, and regulatory compliance.The ideal candidate will be responsible for ensuring...


  • Copenhagen, Copenhagen, Denmark Hamlyn Williams Full time

    We are seeking a talented Validation and Quality Assurance Consultant to join our team at Hamlyn Williams. As a consultant, you will work closely with our clients to understand their validation needs and provide expert guidance on best practices.The successful candidate will have strong experience in validation/CQV within the pharmaceutical industry and a...


  • Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

    We are seeking a talented Pharmaceutical Quality Control and Assurance Professional to join our CMC Development QA organization. As a member of this team, you will play a vital role in ensuring efficient and compliant quality processes to support the development of Small Molecule and Biologic drug candidates, including device activities.Responsibilities will...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    About the TeamSourcing QA is responsible for Quality Assurance of Raw Materials and Packaging Materials going into all of Novo Nordisk's marketed products. We're a close-knit team of 80 dedicated employees working together to ensure the highest quality standards.We collaborate with stakeholders across the organisation and global suppliers to develop and...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Novo Nordisk A/S is a dynamic and innovative company that prioritizes quality and professionalism.Job DescriptionWe are seeking an experienced Quality Assurance Specialist to join our team in Global Contract Manufacturing Drug Substance (GCM DS). As a key member of our QA team, you will be responsible for ensuring the highest standards of quality and...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled and motivated Senior Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring the quality of raw materials and packaging materials going into all of Novo Nordisk's marketed products.You will work closely with suppliers located around the world, ensuring that they meet our...


  • Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

    We are seeking a Quality Assurance Expert - IT who will be responsible for trending and reporting on quality deliverables for management reporting. In collaboration with subject matter experts from the IT organization, you will create and maintain training content that inspires excellence and compliance.About LundbeckLundbeck is a global leader in the...


  • Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full time

    We are seeking a highly motivated Lean Quality Assurance Leader to join our team at Aj Vaccines A/S. As a key member of our Quality Assurance department, you will be responsible for shaping and developing a new role that aligns with our strategic objectives.In this position, you will oversee the QA project portfolio, ensuring effective management and...


  • Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    We are offering a unique opportunity for an innovative and forward-thinking quality assurance professional to establish and develop a new role within our Quality Assurance department. In this position, you will have the freedom to shape and define this role from the ground up, working closely with senior leadership to influence the direction of quality...


  • Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full time

    We are seeking a skilled Quality Assurance Process Strategist to join our team at Aj Vaccines A/S. As a key member of our Quality Assurance department, you will be responsible for shaping and developing a new role that aligns with our strategic objectives.In this position, you will oversee the QA project portfolio, ensuring effective management and alignment...


  • Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    Job Summary:We are seeking a highly skilled Quality and Regulatory Affairs Consultant to join our Clinical and Regulatory team. The ideal candidate will have a strong background in quality assurance and regulatory affairs, with experience in medical devices. You will be responsible for ensuring that our medical devices meet the highest quality standards and...


  • Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    As a regulatory affairs expert at Radiobotics, you will play a pivotal role in ensuring our medical devices comply with international regulations. With a focus on quality assurance and risk management, you will help define and deliver on our strategy to maintain superior product quality.You will collaborate closely with the project manager from the...


  • Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    About the Role:This is an exciting opportunity to join our team as a Medical Device Quality Assurance Specialist. As a key member of our Clinical and Regulatory team, you will be responsible for ensuring that our medical devices meet the highest quality standards. Your expertise in quality assurance and regulatory affairs will play a crucial role in driving...


  • Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    We are seeking a highly skilled Medical Device QA/RA specialist to join our Clinical and Regulatory team at Radiobotics. This is an exciting opportunity for someone with experience in quality assurance and regulatory affairs, who is passionate about ensuring the highest standards of product quality.Company OverviewRadiobotics is a leading company in the...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    About the OpportunityAt Novo Nordisk, we're committed to creating an inclusive culture that celebrates diversity. We believe that everyone has something unique to offer, and we're passionate about developing life-changing treatments that benefit patients around the world.In this role, you will have the opportunity to make a real impact on patient care and...


  • Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    Radiobotics ApS is seeking a highly skilled QA/RA expert to join our Clinical and Regulatory team. As a Medical Device Quality Assurance Specialist, you will play a pivotal role in ensuring the superior product quality and regulatory compliance of our medical devices.The ideal candidate will have at least 1 year of experience in quality assurance and/or...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab is committed to delivering high-quality products and services that meet the needs of patients and healthcare professionals. We're looking for a skilled QA Senior Manager to lead our quality assurance efforts and ensure compliance with regulatory requirements.This is an exciting opportunity to join a dynamic team and contribute to our mission of...