Director, QA Medical Device
Director, QA Medical Device
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Job Description
Are you passionate about Quality Assurance of Medical Devices Do you have leadership experience If so now is your chance to join Ascendis Pharma as our new QA Medical Devices
Ascendis Pharmais a fast-growing global biopharmaceutical company committed to making a meaningful difference in patients lives. We have locations in Denmark Germany the United States the UK Italy Spain and France.
Guided by our core values of Patients Science and Passion we use our TransCon drug development platform to fulfill our mission of developing new therapies selecting only those that demonstrate best-in-class potential to address unmet medical needs.
Today we are advancing programs in Endocrinology Rare Disease and addition we collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.
We are seeking a passionate Director of QA Medical Devices to join our growing organization. As a key member of the Ascendis Pharma team you will play a crucial role in supporting regulatory submissions and global launches of Ascendis Pharma products. 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 manage a team of 3 highly experienced colleagues and be part of the management team reporting directly to the VP of Quality Systems & Compliance QA MD who is based at our Headquaters in Hellerup. You will be based in Hellerup
The QA Director of Medical Devices is accountable for all Quality Assurance activities for Medical Devices and the constituent parts of combination products spanning from development through to product discontinuation. This role involves managing the QA Medical Device team to effectively ensure product quality and compliance and support various functions within Ascendis Pharma.
Your key responsibilities will be:
- Leading and continuously enhancing the Quality Assurance Medical Devices (QA MD) team
- Establishing and continuously improving all Device relevant systems and processes within the Ascendis Pharma Quality Management System (QMS)
- Keeping abreast of regulations standards and guidance relevant to medical devices and combination products
- Managing suppliers including planning and executing supplier audits
- Product Release of components medical devices and constituent parts of combination products
- Ensuring compliance with distribution requirements for Medical Devices under EU Article 14 of the MDR
- Overseeing operational and improvement initiatives related to change control deviations complaints/market feedback and CAPA
- Ensuring QA representation and support in device related development and life-cycle management projects
Qualifications and Skills: You hold a relevant academic degree preferably a Master of Science and 10 years of experience within Quality Assurance of Medical Devices/Combination Products. You are proficient in English at a professional level both written and spoken.
Furthermore you have:
- Leadership experience
- Thorough knowledge of regulations and guidelines for Medical Devices
- Experience with audits inspections and regulatory compliance
- Excellent communication skills
- Ability to collaborate with cross-functional teams
- Experience with managing deviations CAPAs and Change controls
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: Max. 10 days per year.
Office location: Denmark Hellerup
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.
Deadline for Applications: September 15 2025
For more details about the position or the company please contact Ulrik Tolderlund VP Quality Systems & Compliance on Mobileor ULT@
You can learn more about Ascendis by visiting our website
Applications submitted via email or other channels will not be reviewed.
Required Experience:
Director
Employment Type
Full-Time
