Do you have some experience and interest in CMO and supplier management as well as the audit expectations in a life science organisation and open for a maternity position for 12 months to support us in this area?
Then you may be the one we are looking for.
Ascendis Pharma A/S, a visionary and ambitious company, offers you an opportunity to become involved in the development and commercialization of ground-breaking therapies making a meaningful difference to patients.
As QA Manager, you will be responsible for Supplier and Audit Management and take on a lead role in establishing and maintaining a brand-new IT platform with the aim of improving Supplier and Audit Management. You will be involved in the project from A-Z, and furthermore focus on ensuring a strong collaboration between Ascendis Pharma’s network of Auditors.
You will be part of the Supplier and Audit Management team and be an active participant on an exciting journey towards establishing a superior biotech quality organization.
The Supplier and Audit Management team is a small team working closely together with the rest of the Quality System and Compliance teams within Training, QMS, Complaints and IT QA, as well as our colleagues in the QA Development and QA Commercial departments.
You will be part of a dedicated and fun team who is passionate about their work and characterized by their ability to help each other and the stakeholders across the organization.
Criteria of success in the role are to maintain oversight of evaluation and audit of the supplier and CMO landscape and support the right level of life cycle management within. This will provide you with insights in working with the self-inspection program internally and how Ascendis Pharma can apply continuous improvement of their management of all outsourced activities and control of the supplier landscape.
You will collaborate closely with the network of Internal/External Lead Auditors across Ascendis Pharma and keep the QA oversight of Audit planning and the ongoing adherence and performance monitoring to the audit plans.
You will also work closely with regulatory intelligence activities and the process of monitoring of external regulations via a recently established process supported by the Tarius portal.
Your main responsibilities are:
We are looking for a candidate with minimum 3 years of QA experience within the life science industry.
You hold a relevant master’s degree e.g., Natural Science or Engineering.
You have some experience within supplier management and the audit expectations to support and prepare the organization for successful inspections.
You want to work centrally with the quality system processes, with an interest in training the organization in GxP and quality mindset and by that supporting a growing quality culture.
If you have experience with Veeva Vault content management platform, it is an advantage.
Furthermore, you have experience with quality metrics reporting and deriving actions as well as understanding of the manufacturing processes and have knowledge and application of global regulations and guidelines in relation to Biotech/Pharma and/or Device industry.
Moreover, you are proficient in English at a professional level, both written and spoken, and you master MS Office.
As a person we expect you to be pragmatic with an open and communicative approach. You find it important to develop effective relationships with employees at all levels, and you enjoy being in a position with an international reach.
You can actively improve processes involving many stakeholders and drive a quality agenda to develop systems and collaboration across internal and external stakeholders. You are flexible, persistent, and resourceful but still act with a good sense of humour and teamwork skills to support a pleasant daily operational work environment.
Your place of work?will be in the Ascendis Pharma facility in a modern office facility in Tuborg Havn in Hellerup, with a view of the