QA Specialist or Professional for Development GMP activities
3 weeks ago
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 biopharmaceutical Company. Powered by our innovative TransCon technology, we're creating a fully integrated biopharmaceutical enterprise dedicated to transforming the life of patients. Guided by our core principles of patients, science, and passion, we leverage our TransCon drug development platform to pioneer new therapies addressing critical medical needs. Our pipeline consists of several therapies, each designed to set new standards in patient care.
We're on the lookout for a dedicated QA Specialist, or Professional - depending on qualifications, to join our highly skilled QA team in Copenhagen. As a vital contributor at Ascendis Pharma, you'll play a pivotal role in ensuring the QA oversight of the outsourced development activities carried out at our Contract Laboratories and Manufacturing Organizations. Working in a dynamic environment alongside global teams to achieve our final goals to deliver best in class products to our Clinical programs’ remarkable outcomes.
You'll become part of the Development QA - Chemistry team, working closely with 10 colleagues and reporting to Director Jon Wriedt Poulsen, based in Hellerup, Copenhagen, Denmark, where your home base will also be.
Your main responsibilities will include:
- Responsible for driving the Quality Oversight for a development project but also collaborating and contributing to the ongoing work at different other projects in our development pipeline
- Responsible for Quality Oversight of our outsourced complex analytical and manufacturing activities at Contract organizations located all over the globe
- Sparring with the team of highly skilled development SMEs in the CMC department that drives the development, both in-house but also at our Contract Organizations and guiding them in quality related topics, within the quality management system and development / regulatory guideline
- General support the quality work and quality oversight needed for a fast-paced development organization
- Qualifications and Skills:
- You should hold a relevant academic degree, preferably a Masters’ 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, to embrace and develop innovative approaches
- 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: proximately 20 days per year.
Office: Tuborg Boulevard 12, 2900 Hellerup, Copenhagen Denmark
For more details about the job or the company, please contact: Jon Wriedt Poulsen, Director of QA Development Chemistry, jwp@ascendispharma.com. All applications must be submitted in English and are treated confidentially.
Applications will be reviewed as they are received, so please apply promptly.
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timeAbout the RoleAscendis Pharma A/S is seeking a highly skilled Quality Assurance Specialist or Professional to join our Development GMP team in Copenhagen. As a key member of our QA team, you will play a vital role in ensuring the quality oversight of our outsourced development activities.Key ResponsibilitiesDrive Quality Oversight for development projects,...
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Ascendis Pharma A/S. As a key member of our QA team, you will play a vital role in ensuring the quality oversight of our outsourced development activities.Key ResponsibilitiesDrive the quality oversight for development projects and collaborate with our development...
-
GMP professional
4 weeks ago
Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full timeAre you keen to make a difference in your role and do you have strong problem-solving and communication skills? If so, AJ Vaccines are looking for a GMP Professional to join the Inspection & Packaging department. You will be joining a close knitted team and your tasks will include reviewing GMP-documentation, supporting daily operations, and participate in...
-
Associate Director, QA GMP
4 months ago
Copenhagen, Denmark Genmab Full timeThe Role & Department At Genmab we are now looking to further strengthen the Late Stage Development QA Team located in Denmark. In this position, the Quality Assurance (QA) Associate Director will set the quality direction for Genmab’s Late Stage Development products. As GMP QA Associate Director you will be an important part of the global GMP...
-
Biologics Quality Assurance Specialist
5 days ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe are seeking a highly skilled Biologics Quality Assurance Specialist to join our CMC Development QA team at Lundbeck. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.Key ResponsibilitiesProvide QA disposition of Biologic Bulk...
-
GMP Professional
3 weeks ago
Copenhagen, Denmark Lundbeck Full timeGMP Professional, Production GMP Support Are you passionate about quality, compliance, and continuous improvements? Do you have a solid understanding of - and experience with GMP requirements in pharmaceutical production. Then you are the candidate we are looking for to join us as an GMP Professional. Your new role - why is this a great...
-
QA Senior Specialist for facilitet og udstyr
1 month ago
Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full timeVi redder menneskeliv på verdensplan; Vil du være med?Hvis du brænder for at gøre en forskel og sikre kvaliteten af livsvigtige produkter, så er denne stilling måske noget for dig. Vi søger lige nu flere medarbejdere til vores afdeling. Som QA Senior Specialist i QA-afdelingen spiller du en afgørende rolle i vores mission og får mulighed for at...
-
GMP Professional
1 week ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe are seeking a highly skilled GMP Professional to join our team at Lundbeck. As a GMP Professional, you will play a critical role in ensuring the quality and compliance of our pharmaceutical production processes.Key ResponsibilitiesProvide first-line GMP support to production teams, ensuring that all quality-related tasks are completed...
-
GMP Professional
1 week ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe are seeking a highly skilled GMP Professional to join our team at Lundbeck. As a GMP Professional, you will play a critical role in ensuring the quality and compliance of our pharmaceutical production processes.Key ResponsibilitiesProvide first-line GMP support to production teams, ensuring that all quality-related tasks are completed...
-
Medical device QA/RA specialist
1 month ago
Copenhagen, Copenhagen, Denmark Radiobotics Full timeDo you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe you are a seasoned QA specialist that would like to...
-
Medical device QA/RA specialist
1 month ago
Copenhagen, Denmark Radiobotics Full timeDo you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe you are a seasoned QA specialist that would like to...
-
Copenhagen, Copenhagen, Denmark AGC Inc Full timeJob SummaryWe are seeking a highly skilled Scientist, QA Manufacturing Support to join our team at AGC Biologics. As a key member of our Quality Assurance department, you will play a critical role in ensuring the highest standards of quality and compliance in our manufacturing operations.Key ResponsibilitiesQuality Assurance Support: Provide on-site quality...
-
Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Process Improvement Specialist to join our team at Aj Vaccines A/S. As a key member of our Quality Assurance department, you will play a critical role in driving process improvements and implementing Lean methodologies across our organization.Key ResponsibilitiesProject Portfolio Management:...
-
Technical QA Specialist
1 week ago
Copenhagen, Copenhagen, Denmark Coach Solutions Full timeAbout the RoleWe are seeking a highly skilled Technical QA Specialist to join our team at Coach Solutions. As a key member of our Development Department, you will play a crucial role in shaping our testing strategy and implementing mature testing practices throughout the organization.Key ResponsibilitiesCreate comprehensive test plans that outline the...
-
Quality Assurance Specialist
1 week ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeJob SummaryWe are seeking an experienced Quality Assurance Specialist to join our team at Lundbeck A/S, H. As a key member of our commercial manufacturing and distribution processes, you will play a crucial role in strengthening our quality systems and ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and Facilitate Global...
-
Copenhagen, Copenhagen, Denmark AJ Vaccines Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Process Improvement Specialist to join our team at AJ Vaccines. As a key member of our Quality Assurance department, you will play a critical role in shaping and developing our quality assurance processes.Key ResponsibilitiesProject Portfolio Management: Oversee and manage the QA project...
-
Quality Assurance Professional
1 week ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe are seeking an experienced Quality Assurance Professional to join our Corporate Product Quality Systems team at Lundbeck. As a key member of our team, you will play a crucial role in strengthening our commercial manufacturing and distribution processes.Key ResponsibilitiesDevelop and facilitate global and local trainings for our quality...
-
QA Engineer
2 months ago
Copenhagen, Copenhagen, Denmark Anthill Agency AS Full timeJob DescriptionAs an Anthill QA Engineer you will work hands-on with QA tasks and have daily contact with Project Managers, Designers, and Developers to ensure top quality of the product during the development and release cycle. You will be responsible for ensuring that the Anthill Quality standards are upheld throughout the entirety of the products...
-
QA & Support Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Teton Full timeTeton is building AI technology that empowers nurses and frontline care staff to deliver more effective care with less stress. Our solution helps hospitals and care homes maintain critical care standards and patient safety, addressing the global nursing shortage with innovative AI tools.At Teton, we operate differently from traditional companies, with an...
-
Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full timeAbout the RoleWe are seeking a highly skilled and innovative Quality Assurance Process Improvement Specialist to join our team at Aj Vaccines A/S. As a key member of our Quality Assurance department, you will have the opportunity to shape and develop a new role that will significantly impact our quality assurance processes.Key ResponsibilitiesProject...
