Join theQuality Systems amp; Compliance team in a leading and fast-growing biotech company
Ascendis Pharma is currently expanding its Quality Systems amp; Compliance team in order to be ready for commercial products on marked.
As QA Manager you will become responsible for complaint management and information processing. Additionally, you will drive QMS training and Quality improvement initiatives. You will join the Quality Systems amp; Compliance team consisting of dedicated specialists and report to the Senior Director Quality Systems amp; Compliance. Furthermore, you will work globally and have a wide collaboration across the organization.
Criteria of success in the role will be toprocess complaints according to internal procedures and in
collaboration with SME’s and CMO’s. 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.
The successful candidate will identify the need for knowledge and training on complaint handling and establish training programs for all roles involved in the complaint handling process. Additionally, you will manage the oversight of the status of the CMOs qualification program incl. certificates.
Finally, you will optimize the utilization of Veeva Quality Vault for Supplier management.
Main areas of responsibility:
You have minimum 5-7 years of QA experience within the life science industry. Preferably, you have experience with complaint processing of Drug-Device combination products and with implementing and maintaining both processes and associated trainings in a Quality Management Systems in a GxP environment. Furthermore, you are competent within stakeholder management, and have a good business understanding.
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 organization. You are a pragmatic person with an open and communicative approach that is inspired to find new and smart ways to fulfil quality requirements.
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.
Travelling: Approx. 20 days per year.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with
a view to the harbor, the canals, and the sea.
For more details about the job or the company, please contact Consultant Nicolaj Mørk Thomsen on . All applications must be submitted in English and are treated confidentially.
Application will be evaluated when received, so please apply as soon as possible.