Senior Quality Manager – Quality Systems and Compliance

Senior Quality Manager - Quality Systems and Compliance

Ascendis Pharma

Join a leading and fast-growing biotech company.

Ascendis Pharma is a science driven biotech company that works with CROs and CMOs worldwide and operates a global quality system that serves commercial products as well as a very exciting pipeline development programs. This is a unique chance to join an entrepreneurial company on its growth journey and hold a key role in driving key quality processes and influencing Ascendis’ quality strategy and quality management structure.

Continual improvement and maintenance of the Ascendis Quality Management System

As Senior Quality Manager, Quality Systems and Compliance, you will drive the continual improvement and maintenance of the Ascendis Quality Management System. You will assume responsibility for backbone quality systems at Ascendis Pharma and drive development and maintenance in close cooperation with users and stakeholders as well as own global SOPs that are also owned by the Quality Systems group. You will work globally and have a wide collaboration across the organization and towards stakeholders at all levels.

Your role

You will play a key role in ensuring Ascendis’ global key quality processes and collaborate broadly with all stakeholders involved in the processes from Global IT to Manufacturing as well as other departments and collaboration partners using QMS. The role is characterized by being both very cross-organizational and project management oriented.

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

Your main tasks are:

  • Define, design, implement and maintain key quality processes
  • Assume process responsibility and drive and monitor KPIs related to the process
  • Drive improvement projects across Ascendis organization
  • Support regulatory compliance across company site
  • Challenge status quo and continuously seek out more efficient ways of working

Experienced QA Manager with strong QMS competencies

You have solid experience working in biopharma/biotech and you have deep insight in designing and implementing global processes as well as writing clear global SOPs with high involvement of stakeholders in a global context. Most likely you have also worked with change- and project management and understand cultural aspects as important pre-requisites for success. Ascendis is utilizing Veeva as eQMS application – experience with this or similar applications is an advantage.

You have a master’s degree within Pharmacy, Chemistry, or the like, and you are proficient in English at a professional level, both written and spoken.

As a person, you are a pragmatic with an open and communicative approach, and 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.

Apply now

The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Research Manager, Pernille Hemmingsen or Research Consultant, Signe Bülow Hansen on +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.

About Ascendis Pharma
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and established advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with offices in Heidelberg, Germany and Palo Alto, California. For further information, please see

 www.ascendispharma.com.

Deadline forapplication:As soon as possible
Workplace: Tuborg Havn, Hellerup
Reference: 2205.244
Company: Ascendis Pharma