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Senior Quality Manager, Quality Management Systems and Compliance

Make a difference in an exciting and entrepreneurial Danish biopharmaceutical company

As Senior Quality Manager, Quality Management Systems and Compliance at Ascendis Pharma you will drive the continual improvement and maintenance of a flexible and robust quality system that supports development activities as well as the upcoming commercial activities (GMP, GLP, GCP).

Ascendis Pharma is a virtual company that works with CROs and CMOs worldwide. Therefore, you will need to understand the elements necessary to provide excellent external supplier management and oversight, as well as support the organization in establishing/maintaining relevant procedures. The Senior Quality Manager will also have responsibilities within the inspection readiness programs, preparation of Quality Management Review and the coordination of Annual Product Review.

With direct report to the Senior Director of Quality Systems and Compliance, you will become part of a newly established and very dedicated team. To a large degree, you will be able to influence the company’s quality stategy, the quality management structure and the compliance monitoring of Ascendis’ activities.

Your main tasks are:

  • Define, design, implement and maintain easy to comply and easy to follow QM processes
  • Support regulatory compliance across company sites
  • Guide inspection readiness at Ascendis and the CMOs
  • Monitor and drive improvement of KPIs
  • Challenge status quo and continuously seek out more efficient ways of working

Ideally, you have experience working in a pharmaceutical or biotechnological company where quality operations are outsourced. You have a minimum of 8 years of relevant experience and you have previously worked with the establishment of quality systems, preferably in smaller companies. You enjoy building structures and organizing new tasks. You have a proven track record in working with Quality Management Systems and Compliance in a GxP environment. You are proficient in English at a professional level, both written and spoken, and you master MS office.

You have a Master’s Degree within Pharmacy, Chemisty or the like.

As a person, you are a pragmatic person with an open and communicative approach. You like to work as an entrepreneur to find new and smart ways to fulfil quality requirements. You have the ability to develop effective working relationships with employees at all levels and for you, teamwork and collaboration is the key to success. You are flexible, persistent and resourceful.

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 you will work with highly skilled and experienced colleagues on advancing the company’s exciting product pipeline. You will have the opportunity to represent Ascendis in quality conferences, seminars and towards health authorities.

Travelling: 20 days per year.

Domicile: 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 Partner Jørn Duhn, Unique Human Capital on M +45 21 75 19 25. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Stamholmen 157
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
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ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
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