Vi anvender cookies for at forbedre din oplevelse, opsamle statistik og huske indstillinger. Ved at klikke videre accepterer du dette. OK
QMS Manager

In a fast growing biotech company

As QMS Manager at Ascendis Pharma, the main success criteria is to create a good understanding of QMS guidelines and procedures in order to support the different business areas. Ascendis Pharma has just launched a new cloud-based Electronic Document Management System (EDMS) and in cooperation with all functions across Ascendis Pharma worldwide, you will contribute with your knowledge within QMS to ensure compliance according to requirements. You will be part of a global QA team and become part of a very exciting journey taking Ascendis to the next level.

Your main responsibilites are:

  • Drive the implementation of the QMS module of the EDMS
  • Apply your experience and knowledge with Standard Operating Procedures in the establisment and implementation of Ascendis Pharma’s Quality System
  • Design and implement global training processes
  • Handle quality related events such as deviations, change requests, CAPAs etc.

Ideally, you want to work with QMS processes, 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 and your ablity to implement and drive processes involving many global stakeholders.

The successful applicant will have a proven record working with Quality Management Systems in an international pharma, biotech or medical device environment.

The following qualifications are desirable:

  • A minimum of 3-5 years experience within Quality Assurance and an understanding of the manufacturing processes and the guidelines in relation to the pharma industry
  • Extensive experience in drafting SOPs
  • Experience from designing, implementing and conducting training processes
  • Experience with large stakeholder management
  • Experience in audits and inspections – optimally with FDA, EMA and notified bodies

You are proficient in English at a professional level, both written and spoken. You have exellent presentation skills and are familiar with presenting to stakeholders at all levels and functions of the company.

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 and you enjoy being in a position with an international reach. You are flexible, persistent and resourceful. You take on the project lead role 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 an 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 157, 1. tv
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