QA Specialist or Professional for Development GMP activities

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, [email protected]. All applications must be submitted in English and are treated confidentially.

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

Copenhagen