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Director, Quality Management System

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Job Description - Director, Quality Management System

Are you passionate about quality management systems? Do you have experience with leadership?

If so, now is your chance to join Ascendis Pharma as our new Director of QMS.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs. 

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate director to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in the continual development of a best in class quality management system in an excellent Biotech and Pharma Quality Organization. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be leading the Quality Management System team consisting of 6 colleagues, and report directly to the VP of Quality Systems & Compliance, QA MD who is based at our headquarters in Hellerup. You will be based in Hellerup

Your key responsibilities will be:

  • Lead a high performing QA team including managerial responsibility for the team
  • Accountable for the Ascendis Pharma Quality Management system, the Quality Management review, Quality Manual, the Supplier Management system, the GxP training system, and several other key quality processes
  • Maintain and develop the inspection and internal and external auditing process in Ascendis Pharma, audit concepts, drive inspection readiness programs

 

Qualifications and Skills:

You hold a relevant academic degree – preferably a Masters of Science degree – and 10 years of experience within leadership.

Furthermore, you have:

  • An understanding of the manufacturing processes and excessive knowledge and application of global regulations and guidelines in relation to the medicinal products industry
  • A proven leadership record and of track record working with Quality Assurance in an international pharma or biotech environment
  • Extensive experience in global compliance including GxP inspections
  • Experience with large stakeholder management, metrics reporting to senior management teams

 

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.  

To succeed in this role, we also expect you to have

  • Interpersonal skills which enable effective collaboration across cross-functional teams and stakeholders.
  • A comprehensive view and the ability to excel at managing multiple priorities to achieve both short- and long-term goals. 

Travel: < 10 days per year.

Office: Hellerup, DK

Apply now.

Applications will be evaluated when received, so please apply as soon as possible.

All applications must be submitted in English and are treated confidentially.

 

For more details about the position or the company, please contact Ulrik Tolderlund, VP Quality Systems & Compliance, QA MD ULT@ascendispharma.com or visit out website www.ascendispharma.com

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