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QA Specialist or Professional for Development GMP activities

2 months ago

København, 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 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.

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.

Your main responsibilities will include:

  • Driving the Quality Oversight for development projects and collaborating on ongoing work in our development pipeline.
  • Quality Oversight of outsourced complex analytical and manufacturing activities at Contract organizations globally.
  • Collaborating with highly skilled development SMEs in the CMC department and guiding them in quality-related topics within the quality management system and development/regulatory guidelines.
  • Supporting the quality work and oversight needed for a fast-paced development organization.

Qualifications and Skills:

  • 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.
  • Experience with outsourcing of analytical methods and analytical development.
  • Knowledgeable of requirements set by different health authorities and capable of interpreting 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 strategies.
  • Guidance to Stakeholders : Provides clear and actionable guidance to stakeholders.
  • Communication Skills : Excellent ability to convey information and ideas effectively.
  • Analytical Thinking : Strong capability to analyze situations and data for informed decisions.
  • Collaboration : Works well with others to achieve common goals.
  • Adaptability : Easily adjusts to changing circumstances.
  • Independence : Thrives working autonomously and making decisions.

Travel: Approximately 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, All applications must be submitted in English and are treated confidentially.

Applications will be reviewed as they are received, so please apply promptly.

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