Join a Fast Growing Biotech Company
Ascendis Pharma A/S, a visionary and ambitious company, offers you a once-in-a-lifetime opportunity to become a major participant in the further establishment of the structure and function of device development, giving you a unique influence on the way devices will be developed in the future.
As QA Manager, Medical Device, you will hold the key competence within quality oversight of medical devices and combination products.
You will be responsible for the quality assurance of all device activities in development of new device projects and the commercial manufacturing of devices. You will work closely with development and commercial areas internally in Ascendis Pharma and with contract manufacturing organisations (CMOs).
Your key responsibilities:
You hold a relevant Master’s Degree combined with a minimum of 5 years of experience from working with medical device manufacturing or medical device quality assurance. Furthermore, it is an advantage if you have knowledge within combination products. You have extensive knowledge of International, US and EU medical device and combination product regulations and requirements, such as 21 CFR part 820, MDD 1993/42/EEC and ISO 13485, and experience in working with quality aspects of medical device manufacturing, combination products and GMP in general. As you will have frequent, direct communication with CMOs, you must have excellent English communication skills, both spoken and written.
As a person, you are meticulous with a high level of attention to details. You are clear and persistent in your expectations and requirements to quality. However, at the same time being pragmatic and flexible in your approach. You can communicate clearly, both internally and externally towards CMOs and other stakeholders.
At Ascendis Pharma, you will be part of a stimulating, informal and innovative working environment where you will interact with both colleagues and partners to deliver on our ambitious corporate goals. You will be part of an expanding QA-organization overseeing development, clinical and commercial activities
For more details about the job or the company, please contact Senior Consultant Jannie Jensen, Unique Human Capital on M +45 29 72 78 86. All applications must be in English and are treated confidentially
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbour, the canals and the sea.
Ascendis Pharma A/S is an international company with offices in Copenhagen, Germany and the US. Ascendis Pharma is building an integrated biopharmaceutical company to advance its pipeline of long-acting prodrug therapies. They employ their proprietary TransCon technology platform to generate therapeutics with best-in-class profiles that address large markets with significant unmet medical needs. Ascendis Pharma has a diversified and balanced high-value product pipeline, including internal programs and partnerships with market leaders.
For further information, please see www.ascendispharma.com