Senior QA Manager - Medical Devices and Combination Products
Join a leading and fast-growing biotech company
Ascendis Pharma A/S, a visionary and ambitious company, offers you a unique opportunity to be part of establishing a world class competence center for quality assurance of medical devices and device constituent parts of combination products.
Quality Assurance from development to commercialization
As Senior QA Manager for Medical Devices and Combination Products, you will hold the key competence for quality management of medical devices and device constituent parts for combination products from development to commercialization. You will be responsible for quality assurance of device R&D activities, risk management, validation activities, as well as manufacturing activities and release of medical devices to the market.
You will become part of a newly established competence center for quality assurance of medical devices and device constituent parts and report directly to the QA Director. You will act as a QA strategic partner concerning matters related to medical devices and device constituent parts and work closely with R&D and manufacturing organizations in Ascendis Pharma and externally with contract manufacturing organizations (CMOs).
Your key responsibilities:
- Provide guidance to the life cycle management of medical device and device constituent parts of combination products.
- Review and approve design control and manufacturing documents.
- Review and approve on behalf of QA regulatory submission documents including clinical trial applications.
- Release medical devices to the market.
- Ensure that all activities are conducted in compliance with Ascendis’ QMS and relevant regulatory requirements.
- Drive and assist in establishing new procedures and improvement of existing.
- Management of suppliers/CMOs for medical devices and device constituent parts.
- Participate in suppliers/CMO’s audits as medical device and assembly and packaging quality SME.
- Handle Ascendis and suppliers/CMOs medical device related deviations, non-conformities, and changes.
- Keep abreast with relevant medical device and combination product regulations, standards, and guidance’s.
Medical Device expert with business acumen and QA mind-set
You hold a natural science degree and a minimum of 5 years of experience from working with medical device R&D, manufacturing and/or quality assurance activities. You have experience with US and EU medical device and/or combination product regulations and standards, such as 21 CFR part 820, MDD/MDR and ISO 13485, as well as experience from working with quality aspects of medical device development, combination products or GMP in general. As you will have frequent, direct communication with suppliers/CMO’s, you must have excellent English communication skills, both spoken and written.
As a person, you are clear and persistent in your expectations and requirements to quality. At the same time, you bring business acumen and are pragmatic and flexible in your approaches. You are meticulous with an appropriate level of attention to details. Furthermore, you are self-motivated and able to work independently.
You can communicate clearly, both internally and externally towards suppliers/CMOs and other stakeholders.
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 Partner, Rasmus Meyhoff or Research Manager, Pernille Hemmingsen on telephone +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
At Ascendis Pharma, you will be part of a stimulating, informal and innovative working environment where you will interact with both colleagues and partners to deliver on Ascendis’ ambitious corporate goals. You will be part of an expanding QA-organization overseeing R&D, clinical and commercial activities.
Deadline for application: As soon as possible
Company: Ascendis Pharma