Director, QA Medical Device

Hellerup, Hovedstaden
Permanent
Fuldtid

20 dage siden
Nem ansøgning

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 DevicesAscendis 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 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 HellerupThe 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, HellerupApply nowApplications 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 2025For more details about the position or the company, please contact Ulrik Tolderlund, VP Quality Systems & Compliance on Mobile + 45 5166 6630 orYou can learn more about Ascendis by visiting our websiteApplications submitted via email or other channels will not be reviewed.

Ascendis Pharma