QA Professional/Associate - Complaint Management

Are you passionate about Patient Safety? Do you have experience within Complaint Handling?

If so, now is your chance to join Ascendis Pharma as our new QA Manager.

Ascendis Pharma is a fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. We have locations in Denmark, Germany, the United States, the UK, Italy, Spain, and France.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.

Today, we are advancing programs in Endocrinology Rare Disease and Oncology. In addition, we collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.

We are seeking a passionate QA Professional/Associate to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in complaint management and handle complaint processes regarding both marketed products as well as products in Clinical Development. You will work globally and have wide collaboration across the organization and towards CMOs. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the Complaint Management team consisting of 5 colleagues, and report directly to Karina Bergenholtz, Director QAwho is based in Hellerup.You will be based in Helleup.

Your key responsibilities will be:

• Complaint management, incl. support, coordination and contact to stakeholders
• Drive quality improvement initiatives across the organization

Qualifications and Skills:

You have minimum 2-5 years of experience within the life science industry and experience working with GMP regulations. Preferably, you have experience with complaint processing of either drugs, medical devices and/or drug-device combination products. Furthermore, with a good business understanding, you thrive in a dynamic environment with many exciting and varied work tasks.  

To succeed in this role, an educational background in Natural Science on bachelor level or similar is required. You are proficient in English at a professional level, both written and spoken, and you master MS Office.

On a personal level, you are a highly motivated and self-driven individual who enjoys being challenged and working in collaborative environments. With your structured style of working, you are positive, and service minded. Moreover, you are pragmatic with an open and communicative approach and is thus inspired to find new and smart ways to fulfil quality requirements.

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.  

Apply now.

Applications will be evaluated when received, so please apply as soon as possible.

All applications must be submitted in English and are treated confidentially.

For more details about the position or the company, please contact Karina Bergenholtz, Director QA [email protected] or visit out website www.ascendispharma.com