Senior Quality Assurance Specialist for Biopharmaceutical Development

4 days ago


Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

About the Role

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Ascendis Pharma A/S in Copenhagen, Denmark. This is an exciting opportunity to be part of a dynamic biopharmaceutical company that is transforming the lives of patients.

The ideal candidate will have a strong background in Quality Assurance with experience in outsourced GMP activities and development projects. As a Senior Quality Assurance Specialist, you will play a crucial role in ensuring the quality oversight of our outsourced development activities carried out at Contract Laboratories and Manufacturing Organizations.

You will become part of the Development QA - Chemistry team, working closely with 10 colleagues and reporting to Director Jon Wriedt Poulsen. Your main responsibilities will include driving the Quality Oversight for development projects, collaborating with teams, and guiding them on quality-related topics within the quality management system and development/regulatory guidelines.

Key Responsibilities

  • Drive the Quality Oversight for development projects
  • Collaborate with teams on quality-related topics
  • Guide teams on quality management system and development/regulatory guidelines
  • Support the quality work and quality oversight needed for a fast-paced development organization

Requirements

  • Relevant academic degree, preferably a Master's degree in Pharmaceutical sciences, Chemistry, Biotechnology, Engineering or equivalent
  • 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

Benefits

  • Competitive salary: DKK 650,000 - DKK 750,000 per year (approximately USD 95,000 - USD 110,000)
  • 20 days of travel per year
  • Tuborg Boulevard 12, Hellerup, Copenhagen, Denmark as your home office
  • A supportive and collaborative work environment

Ascendis Pharma A/S

We are a biopharmaceutical company with a mission to transform the lives of patients. We leverage our innovative TransCon technology to create fully integrated biopharmaceutical enterprises dedicated to delivering best-in-class products to clinical programs. Our pipeline consists of several therapies designed to set new standards in patient care.



  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    At Ascendis Pharma A/S, we're driven by our passion for transforming patients' lives through innovative therapies. Our cutting-edge TransCon technology has enabled us to establish a fully integrated biopharmaceutical enterprise with a strong presence in Denmark, Germany, and the United States.We're currently seeking a skilled Development Quality Assurance...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    Ascendis Pharma A/S offers an exciting opportunity to join our GCP Quality team as a Senior Quality Assurance Manager. We are a leading biopharmaceutical company with locations in Denmark, Germany, and the United States.About UsWe apply our TransCon technology to build a fully integrated biopharmaceutical company focused on making a meaningful difference in...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    About the Role:We are seeking a highly skilled Senior GCP Quality Assurance Specialist to join our growing team at Ascendis Pharma A/S. This is an exciting opportunity to work in a dynamic and international environment with a short line of command.Job Description:The Senior GCP Quality Assurance Specialist will be responsible for ensuring compliance with...


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    OverviewNovo Nordisk A/S is a global healthcare company that discovers, develops, and manufactures innovative medicines for patients with chronic diseases. We are seeking an experienced Senior Quality Assurance Specialist to join our team in Gentofte, Denmark.


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    About the RoleNovo Nordisk A/S seeks a skilled Quality Assurance Specialist to join their team in Gentofte, Denmark.The ideal candidate will have a strong background in the pharmaceutical industry, with a focus on quality assurance and control. The role will involve ensuring that products meet the highest quality standards, as well as overseeing the...


  • Gentofte, Gentofte Kommune, Denmark Saxo Bank AS Full time

    Career Progression: Senior Quality Assurance Analyst at Saxo Bank A/SAbout the JobSaxo Bank A/S is seeking a Senior Quality Assurance Analyst to join its expanding AML Quality Team at its headquarters in Copenhagen. The team is undergoing a transformation, focusing on quality assurance of Nordic and institutional clients to elevate and monitor the AML...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    About the RoleWe're seeking a skilled Quality Assurance Specialist to join our Development QA team in Copenhagen. As a vital contributor, you'll play a key role in ensuring the quality oversight of outsourced development activities at our Contract Laboratories and Manufacturing Organizations.Main ResponsibilitiesDrive quality oversight for development...


  • Gentofte, Gentofte Kommune, Denmark Saxo Bank AS Full time

    About Saxo Bank A/SWe are a leading online trading and investment firm, and we are looking for a talented Quality Assurance Analyst to join our team in Copenhagen, Denmark.Job SummaryWe are seeking a highly skilled Quality Assurance Analyst to develop and implement quality standards, conduct tests, and identify issues in our ONB and ODD processes. The...


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    About the PositionWe are looking for a Senior Quality Professional to join our team in Finished Products Manufacturing (FPM) Quality Assurance (QA). The role will involve planning, running, and following up on GMP inspections in close cooperation with the corporate inspection office and manufacturing sites.


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    Are you a skilled professional with experience in quality assurance and production in the pharmaceutical industry? Do you thrive in a constantly changing environment with various challenges and find it rewarding to develop colleagues?As a Quality Assurance Specialist in our Aseptic Manufacturing department, you will be responsible for ensuring the highest...


  • Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full time

    Are you passionate about ensuring the highest quality of patient handling solutions?About the Role:We are seeking a highly skilled Quality Assurance Specialist to join our Patient Handling Division. As a key member of our team, you will be responsible for all quality assurance activities within the division, including regulatory approvals, quality management...


  • Gentofte, Gentofte Kommune, Denmark Best Talent Full time

    Company Overview">Ascendis Pharma A/S, a U.S. publicly held biopharmaceutical company founded in Copenhagen, Denmark in 2007, is committed to addressing unmet medical needs.">The company's mission is to develop new and potentially best-in-class therapies using their innovative platform technology.">Headquartered in Copenhagen, Denmark, Ascendis Pharma has...


  • Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full time

    Job Description:This role offers a unique opportunity to make a positive impact on patient care and support. As Patient Handling Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards in patient handling equipment and services.About Us:We are a global leader in the development of innovative assistive devices and...


  • Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full time

    Make a meaningful impact on patient care worldwide as a Quality Assurance Specialist in our Patient Handling Division.As a key member of our team, you will be responsible for ensuring the quality and compliance of our patient handling products and services.Your key tasks will include:Developing and implementing quality assurance processes aligned with...


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    You will be appointed as Quality Manager for Aseptic Manufacturing in Gentofte and be responsible for the release of drug products to the market, appoint and support QP delegates and other colleagues in the department.As a Quality Manager, you will set the direction for quality in our area, ensuring the highest quality to patients in a changing and...

  • Senior Microbiologist

    3 weeks ago


    Gentofte, Gentofte Kommune, Denmark Novo Nordisk Full time

    We are seeking a highly skilled Senior Microbiologist to join our Quality Control team at Novo Nordisk. This is an exciting opportunity to work with a talented group of professionals who share your passion for microbiology and quality assurance.About the RoleAs a Senior Microbiologist, you will be responsible for ensuring the highest standards of quality in...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    About the roleWe are seeking a skilled Senior GCP Quality Specialist to join our GCP Quality team at Ascendis Pharma A/S. As a key member of our team, you will be responsible for ensuring compliance with global GCP requirements and maintaining high-quality standards in our clinical development operations.Main responsibilitiesCollaborate with internal...


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    We are looking for a skilled Aseptic Quality Assurance Expert to join our team at Novo Nordisk A/S.Estimated salary: 95,000 - 120,000 DKK per year, depending on experience.About the roleYou will be responsible for ensuring the highest quality of drug products in our aseptic manufacturing area. This includes setting direction for quality, ensuring compliance...


  • Gentofte, Gentofte Kommune, Denmark Best Talent Full time

    Company Overview:Ascendis Pharma A/S is a U.S. publicly held biopharmaceutical company founded in Copenhagen, Denmark in 2007, committed to addressing unmet medical needs. The company applies its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients' lives.The company...


  • Gentofte, Gentofte Kommune, Denmark Unique Human Capital AS Full time

    Drive Quality ExcellenceAbout the Role: As a Quality Assurance Manager at Unique Human Capital A/S, you will play a vital role in ensuring the ongoing performance, safety, and compliance of our Patient Handling products. With direct report to the CEO of the Etac Patient Handling Division, you will work closely with the Etac Group Quality and Regulatory...