Quality Assurance Professional for Development Activities

4 days ago


Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time

At Ascendis Pharma A/S, we are seeking a Quality Assurance Professional to join our highly skilled QA team in Copenhagen.

This individual will play a pivotal role in ensuring the QA oversight of outsourced development activities carried out at Contract Laboratories and Manufacturing Organizations.

The successful candidate will be responsible for driving quality oversight for development projects and collaborating with global teams to achieve remarkable outcomes.

We offer a dynamic environment where you can work closely with 10 colleagues and report to Director Jon Wriedt Poulsen, based in Hellerup, Copenhagen, Denmark.

Your main responsibilities will include:

  • Responsible for quality oversight of outsourced complex analytical and manufacturing activities at Contract organizations located globally.
  • Sparring with development SMEs in the CMC department to drive quality related topics within the quality management system and development/regulatory guidelines.
  • General support of quality work and quality oversight needed for a fast-paced development organization.

Qualifications and Skills:

  • A relevant academic degree, preferably a Master's degree in Pharmaceutical sciences, Chemistry, Biotechnology, Engineering or equivalent with more than 2 years of experience in a GMP environment.
  • Accustomed to working with outsourcing of analytical methods and analytical development.
  • Knowledgeable with requirements set out by different health authorities and interpretation of these.

Key Competencies:

  • Curiosity: Demonstrates a strong desire to learn and understand new concepts and ideas.
  • Solution-Oriented: Focuses on identifying and implementing effective solutions to problems proactively.
  • Pragmatic Mind-Set: Approaches tasks and challenges with practical and realistic strategies.
  • Guidance to Stakeholders: Provides clear and actionable guidance and sparring to both internal and external stakeholders.
  • Communication Skills: Excellent ability to convey information and ideas effectively.
  • Analytical Thinking: Strong capability to analyze situations and data to make informed decisions.
  • Collaboration: Works well with others to achieve common goals.
  • Adaptability: Easily adjusts to changing circumstances and environments.
  • Independence: Capable and thriving working autonomously and making decisions.

Travel: Approximately 20 days per year. Office: Tuborg Boulevard 12, 2900 Hellerup, Copenhagen, Denmark.



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

    Quality Assurance Professional, Quality Assurance Requisition ID: 5620 Location: Copenhagen, Danish Capital Region, DK Quality Assurance Professional, Quality Assurance Are you eager to apply your strong quality mindset in strengthening Lundbeck's commercial manufacturing and distribution processes? Are you motivated by influencing the way we work with...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Do you have a passion for Quality Assurance and are eager to support and improve processes surrounding the flow of raw materials and packaging materials? Are you ready to tackle diverse challenges and collaborate with cross-functional teams in a dynamic environment? If yes, then apply now to join us and experience a life-changing careerThe positionAs an...


  • Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time

    Passionate about Quality Assurance with expertise within outsourced GMP activities and development projects? Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities. With roots spanning Denmark, Germany, and the United States, Ascendis Pharma A/S emerges as an innovative and dynamic...


  • Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time

    Passionate about Quality Assurance with expertise within outsourced GMP activities and development projects?Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities.With roots spanning Denmark, Germany, and the United States, Ascendis Pharma A/S emerges as an innovative and dynamic...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Select how often (in days) to receive an alert: Create AlertQuality Assurance Professional in External Supply SourcingCategory: QualityLocation: Bagsværd, Capital Region of Denmark, DKDo you have a passion for Quality Assurance and are eager to ensure top-notch supplier standards? Are you ready to tackle diverse challenges and collaborate with...


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

    Lundbeck A/S, H is seeking a highly skilled Quality Assurance Specialist to join its CMC Development team.The successful candidate will be responsible for ensuring the quality and integrity of Investigational Medicinal Products (IMPs) used in clinical trials. This involves reviewing batch records, assessing QA deviations, change controls, and laboratory...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. As a Quality Assurance and Control Professional, you will be responsible for ensuring the highest standard of quality in our products. You will work closely with the production team to ensure that...


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

    Job DescriptionIn this role, you will be responsible for:Technical lead and subject matter expert for Quality Control activities with focus on drug-device combination products.Working closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities.Reviewing and approving protocols, reports, and other documents...


  • Copenhagen, Copenhagen, Denmark Pandora AS Full time

    Pandora A/S is seeking a Quality Assurance Lead to join our team in Copenhagen V, DK. As a key member of our quality engineering and assurance teams, you will play a crucial role in ensuring the quality of our e-commerce platforms, retail technology, and order management systems.The ideal candidate will have extensive experience in quality engineering and...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a skilled Quality Assurance Specialist to join our team in Emerging Technologies API Manufacturing Development (ET API MDev). As a key member of our organization, you will play a crucial role in ensuring compliance with GxP guidelines and regulations.Key ResponsibilitiesAct as a one-point-of-entry for audits and inspections,...


  • 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 Novo Nordisk AS Full time

    Job DescriptionWe are seeking a highly motivated and self-confident individual to join our Supply Chain QA team as an Implementation Lead QA within Warehouse. This is an exciting opportunity for a solution-oriented professional with a passion for working in Quality Assurance to transform requirements into simple and compliant solutions that meet the needs of...


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

    We are seeking a highly motivated and experienced Global Quality Assurance Trainer to join our team at H. Lundbeck A/S. As a Global Quality Assurance Trainer, you will play a critical role in ensuring that our training programs meet the highest standards of quality and effectiveness.About the RoleThe successful candidate will be responsible for designing and...


  • Copenhagen, Copenhagen, Denmark ReFlow Full time

    We specialize in lifecycle assessment (LCA) and corporate GHG emissions consultancy, delivering transparent and traceable data to clients across various sectors.As pioneers in vessel LCA, we integrate scientific approaches into practical solutions. Our team is seeking a skilled and detail-oriented Developer/QA Engineer to join our growing development...


  • Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    Radiobotics is seeking a skilled Medical Device Quality Assurance Specialist to join our Clinical and Regulatory team. As a key member of this team, you will play a central role in maintaining superior product quality and placing our products on new markets.As a QA/RA specialist, you will become the expert in all corners of our Quality Management System. You...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Job DescriptionThe Quality Assurance Manager will be responsible for ensuring that all aspects of quality are met within the organization. This includes overseeing quality requirements for technical product transfer and lab methods, participating in project meetings, and developing quality oversight strategy.The Quality Assurance Manager will interact with...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    About the DepartmentThe Supply Chain QA department is responsible for Quality Assurance of and support to Supply Chain Planning and Logistic activities, including cold chain distribution of Novo Nordisk products worldwide, production planning across the entire Novo Nordisk supply chain, and data management and governance across Novo Nordisk. Our department...


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

    About the PositionWe are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics Quality Control team.As our Senior Quality Control Scientist, you will be responsible for technical leadership and subject matter expertise in Quality Control activities with a focus on drug-device combination products.You will work closely with...


  • 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 AJ Vaccines Full time

    We are seeking a seasoned Quality Assurance professional to join our team as a LEAN and Six Sigma leader. In this role, you will have the opportunity to shape and develop new processes within our Quality Assurance department. Reporting directly to the Senior Director of QA, you will collaborate closely with senior leadership to influence strategic direction...