GMP Quality Assurance Professional

2 days ago


Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

We are looking for a talented GMP Quality Assurance Professional to join our Development QA - Chemistry team at Ascendis Pharma A/S. In this role, you will play a pivotal part in ensuring the quality oversight of our outsourced development activities carried out at Contract Laboratories and Manufacturing Organizations.

About Our Company

As a leading biopharmaceutical company, we are committed to pioneering new therapies addressing critical medical needs through our innovative TransCon technology. With a strong presence in Denmark, Germany, and the United States, we aim to transform patient lives by delivering best-in-class products.

Key Responsibilities:
  • Ensure quality oversight of outsourced complex analytical and manufacturing activities at Contract organizations worldwide.
  • Sparring with the team of highly skilled development SMEs in the CMC department, guiding them in quality-related topics within the quality management system and development/regulatory guidelines.
  • General support the quality work and quality oversight needed for a fast-paced development organization.

The ideal candidate will hold a relevant academic degree, preferably a Master's degree in Pharmaceutical sciences, Chemistry, Biotechnology, or Engineering, with more than 2 years of experience in a GMP environment. A strong background in outsourcing of analytical methods and analytical development is required. Excellent communication skills, analytical thinking, and problem-solving abilities are essential for success in this role.

Qualifications and Skills
  • Relevant academic degree (Master's degree in Pharmaceutical sciences, Chemistry, Biotechnology, or Engineering).
  • More than 2 years of experience in a GMP environment.
  • Strong background in outsourcing of analytical methods and analytical development.
  • Excellent communication skills.
  • Analytical thinking and problem-solving abilities.

Travel: Approximately 20 days per year. Jon Wriedt Poulsen, Director of QA Development Chemistry, is happy to answer any questions you may have about this position or Ascendis Pharma.



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