Ascendis Pharma A/S is currently expanding its Quality Systems amp; Compliance team to be ready for commercial products on the market. This position is therefore a unique chance to join an entrepreneurial company on its growth journey and hold a key role in complaint management, handling complaint processes and establishing training in these processes.
Complaint Management and Quality improvement
As QA Manager, you will become responsible for complaint management and handle complaint processes regarding both marketed as well as development products. Additionally, you will drive QMS training and Quality improvement initiatives. You will join Quality Systems amp; Compliance consisting of dedicated specialists and report to Head of the Complaint Management amp; Training team. As you will be working across different sites of Ascendis Pharma and towards CMOs, you will have wide collaboration globally and manage stakeholders at all levels.
Criteria of success in the role will be to process complaints according to internal procedures and in collaboration with SMEs and CMOs. Furthermore, you will provide data trend for the complaint process and oversee follow-up activities such as CAPA’s, deviations and change controls related to the activities.
Further, you will have the opportunity for working on quality system activities and projects within the project portfolio.
Main areas of responsibility:
Self-driven QA Manager with Complaint Management experience
You have minimum 1-3 years of QA experience within the life science industry. Preferably, you have experience with complaint processing of either drugs, medical devices and/or drug-device combination products as well as with implementing and maintaining both processes and associated trainings in a Quality Management System in a GxP environment.
You have a master’s degree, preferably in Natural Science. You are proficient in English at a professional level, both written and spoken, and you master MS Office.
You are a highly motivated and self-driven individual who enjoys being challenged and working in collaborative environments. Strong interpersonal skills are necessary as you will be working across different sites of Ascendis Pharma and have a significant role in the organisation. You are a pragmatic person with an open and communicative approach that is inspired to find new and smart ways to fulfil quality requirements.