Senior Quality Assurance Specialist for Biopharmaceutical Development
4 days ago
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.
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