QA Coordinator - Life Cycle Management

Do you want to make a difference for patients living with unmet medical needs? Ascendis Pharma A/Sis a visionary and ambitious company, and we are in the process of expanding our global footprint. We offer you an opportunity to become part of this exciting journey.

The person will be a part of the QA Drug Product & Finished Goods team in the QA Commercial Operations department but supporting the whole department cross-functionally.

QA Drug Product & Finished Goods is a small well-functioning team with responsibility for quality oversight of drug product and finished goods for commercial products. Ascendis Pharma is in the process of expanding our global footprint by entering partnerships and launching in new countries and here we need your help with partner life cycle management (information to partners, handling of incoming questions from partners etc.)

Example of tasks could be:

• Close collaboration with internal stakeholders for quality related questions from partners and CMOs from all over the world, affiliates and from within the company (Regulatory Affairs, Commercial Operations etc.)
• Establishing the infrastructure for archival and traceability of requested documents
• In close collaboration with internal QA operational teams prepare the documentation package required by partners for every batch shipment.
• Establish and maintain a process for document and/or information requests, request from partners (e.g. partner submissions, due diligence, life cycle management).
• Establish and maintain process for providing documents and/or information required for regulatory submissions.
• Co-ordinating audits from partners
• Establishing process for and creation of partner specific documents, e.g. CoA/CoCs

The position will require a person that has the following competencies:

• Experience from the Pharma industry and understanding of the many requirements related to medicinal products
• Strong communication skills
• Interest in working with different cultures
• Likes to create structure and work in a structured way.
• Works independently

You will be part of a small well-functioning department where we highly value each other’s well-being and the growth of professional and personal skills. Ascendis is located in very nice facilities in Hellerup and offers great work flexibility.

The position as Partner life cycle management is a position that requires the willingness to work with routine tasks with the opportunity to add on more complex assignments. You should be proficient in English at a professional level, both written and spoken, and you master MS Office.

At Ascendis Pharma, you will be part of a stimulating, informal, and innovative working environment, where you will interact with very skilled colleagues and partners to deliver on Ascendis’ ambitious corporate goals. You will be part of an expanding QA-organization overseeing development, clinical, and commercial activities.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.

For more details about the job or the company, please contact QA Director, Nina Bornhøft Nielsen, M +45 30 19 19 02. All applications must be submitted in English and are treated confidentially.

Hellerup