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 Senior QA Manageryou will assume responsibility for Ascendis Pharma complaint management system and ensure procedures, system, Key Performance Indicators and Quality Assurance Agreements are in place with the partners engaged in the processes. Further, you will be the responsible for our training process as well as other key QMS processes. 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.
Ascendis Pharma is a virtual biotech company that works with CROs and CMOs worldwide. Therefore, it is crucial you understand the elements necessary to provide excellent external supplier management and oversight, as well as support the organization in establishing/maintaining relevant procedures.
Criteria of success in the role will be to ensure processing of complaints according to internal procedures and in collaboration with SME’s and at CMO level. Furthermore, you will provide and analyze date 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. Proven ability to strategically make and be accountable for decisions to meet the ever growing and changing stringent global regulatory requirements. Furthermore, strong attention to detail in establishing priorities, scheduling, and meeting deadlines.
Main areas of responsibility:
You have minimum 8 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/year.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup witha view to the harbor, the canals, and the sea.
For more details about the job or the company, please contact Senior Director Lars Dreiøe on +45 50899525 or . All applications must be submitted in English and are treated confidentially. Applications will be evaluated when received, so please apply as soon as possible.
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of thre