Development Quality Assurance Specialist for Biopharmaceuticals

4 weeks ago


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 Specialist to join our dynamic QA team in Copenhagen. As a vital contributor, you'll play a pivotal role in ensuring the quality oversight of outsourced development activities at our Contract Laboratories and Manufacturing Organizations.

Your primary responsibilities will include:

  • Driving Quality Oversight for development projects while collaborating with colleagues on ongoing work across various pipeline initiatives.
  • Ensuring Quality Oversight of complex analytical and manufacturing activities at Contract organizations worldwide.
  • Sparring with highly skilled CMC department SMEs to guide them in quality-related topics within our quality management system and regulatory guidelines.
  • Providing general support for quality work and oversight in a fast-paced development environment.

To excel in this role, you should possess a relevant academic degree, preferably a Master's in Pharmaceutical sciences, Chemistry, Biotechnology, or Engineering, with more than 2 years of experience in a GMP environment.

You should also be accustomed to outsourcing analytical methods and development, knowledgeable about health authority requirements, and able to interpret these effectively.

The ideal candidate will demonstrate strong curiosity, solution-oriented thinking, pragmatism, guidance skills, excellent communication abilities, analytical thinking, collaboration skills, adaptability, and independence.

This is an excellent opportunity to join a dynamic team and contribute to the success of our biopharmaceutical company. We offer a competitive salary range of €65,000 - €85,000 per year, depending on qualifications and experience. Travel is approximately 20 days per year, and your home base will be located at Tuborg Boulevard 12, 2900 Hellerup, Copenhagen, Denmark. If you're interested in learning more, please don't hesitate to reach out.



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