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QMS Coordinator, Development QA

In a fast growing biotech company

As QMS Coordinator at Ascendis Pharma, the main success criteria is to create a good understanding of guidelines and procedures to support the business. Ascendis Pharma has just launched a new cloud-based Electronic Document Management System (EDMS) and in cooperation with 5 Development QA colleagues, you will contribute with knowledge and support to your stakeholders at Ascendis Pharma.

You report directly to the Senior Director QA and will become part of a very dedicated and experienced team.

Your main responsibilites are:

  • Apply your experience and knowledge within Standard Operating Procedures to maintain and improve Ascendis Pharma’s Quality System
  • Participate in the implementation of the QMS module of the EDMS
  • Handle quality related events such as Deviations, Change Requests, CAPAs etc in the QMS module
  • Define, design, and implement new areas of the QMS
  • Document management and archiving, particularly related to the Ascendis Pharma GxP archive

Ideally, you want to work with EDMS and QMS, and you hold a relevant degree within e.g. Pharmacy, Biology, Biochemistry, Chemistry, a technical field, Library and Information Science or the like. However, most important is your experience with QMS.

The successful applicant will have a proven record working with Quality Management Systems in a project driven GxP environment.

The following qualifications are desirable:

  • A minimum of 3-5 years of experience within Quality Assurance
  • Extensive experience in drafting SOPs
  • Experience from a project driven GxP organization is an advantage
  • Experience with large stakeholder management and training

You are proficient in English at a professional level, both written and spoken, and you master MS Office.

You are a pragmatic person with an open and communicative approach, and you have the ability to develop effective working relationships with employees at all levels. You are flexible, persistent and resourceful. You take on routine jobs when necessary, and you identify and deliver support with a high level of drive.

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 on advancing our exciting product pipeline.

Travelling: Approx. 5-10 days / year

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 Senior Consultant, Jannie Jensen, Unique Human Capital on M: +45 29 72 78 86. All applications must be submitted in English and are treated confidentially.

 

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

Kontakt
Unique Human Capital A/S
cvr: 31502705

Stamholmen 151
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
T +45 7020 6700
Marselis Tværvej 4
8000 Aarhus C
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland
T + 48 22 291 32 20