QA Associate, Complaint Management

Ascendis Pharma; Hellerup; On-site; DKK 550,000 - 750,000; Full time

Job summary

Ascendis Pharma in Hellerup, Denmark, is seeking a QA Associate/QA Professional to join the Complaint Management Department. You will handle complaint processes for marketed products and products in Clinical Development, coordinating with global teams and CMOs.

The role requires a background in Natural Science with 2–5 years in life science, experience with GMP, and proficiency in English. You will report to Karina Bergenholtz, Director QA.

Qualifications

• Educational background in Natural Science with 2–5 years life science experience.
• Experience with GMP regulations.
• Experience with complaint handling for pharmaceutical products or medical devices.

Responsibilities

• Handle complaints in Veeva QMS, including support and coordination with stakeholders.
• Drive quality improvement initiatives across the organization.

Skills

Complaint handling

GMP regulations

English professional level

Education

Natural Science degree

Tools

Veeva QMS

Job description

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 Associate/Professional.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients' lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate QA Associate/QA Professional 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 Department consisting of 8 colleagues, and report directly to Karina Bergenholtz, Director QAwho is based in Hellerup. You will be based in Hellerup.

Your key responsibilities will be:

• Complaint handling in Veeva QMS, incl. support, coordination and contact to stakeholders
• Drive quality improvement initiatives across the organization

Qualifications and Skills:

You have an educational background in Natural Science with minimum 2-5 years' experience within the life science healthcare industry. Additionally, we expect that you have experience working with GMP regulations.

Furthermore, you have:

• Experience with complaint handling for pharmaceutical products, medical devices and/or drug-device combination products
• The ability to manage multiple tasks and priorities in a dynamic, fast-paced environment
• A structured and quality-focused approach to operational tasks
• Proficiency in written and spoken English at a professional level

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.

To succeed in this role, we also expect you to be self-driven and like to work in a collaborative environment. Moreover, you are pragmatic with an open and communicative approach and is thus inspired to find new and smart ways to fulfil quality requirements.

Travel:

0 days per year.

Office:

Tuborg Boulevard 12, 2900 Hellerup

Applications must be submitted in English and will be treated confidentially.

For more details about the position or the company, please contact Karina Bergenholtz, Director QA, [e-mail]

You can learn more about Ascendis by visiting our website www.ascendispharma.com