Sr. Specialist, QA QMS

Are you passionate about Quality Assurance? Do you have experience within Supplier/Vendor Management?

If so, now is your chance to join Ascendis Pharma as our new Senior Specialist.

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 Senior Specialist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in coordinating Supplier Management. You will join a team consisting of dedicated specialists and report to Head of the QA QMS. 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 joining the QA QMS (Quality Management Systems) team consisting of 9 colleagues, and report directly to Senior Director and Head of QMS,who is based in Hellerup.

Your key responsibilities will be:

• Maintaining and improving Ascendis Supplier- and Vendor lifecycle management process.
• Process ownership of Supplier Quality Management System in Ascendis QMS
• Supporting relevant stakeholders in the Supplier Quality Management System
• Provide support for Ascendis stakeholders working with Ascendis Partners and Affiliates
• Development- and training of users in the Supplier Quality Management System.
• Document Control Management of GxP documents at Ascendis Pharma
• Drive GxP process improvement initiatives across the organization

Qualifications and Skills:

You hold a relevant academic degree – preferably a Master (or similar) degree, with experience from supplier management from the medicinal industry.

You have:

• 5-10 years experience within Quality and an understanding of the quality processes and excessive knowledge and application of global regulations and guidelines in relation to the medicinal products industry
• Extensive experience with supplier lifecycle management
• Extensive experience with Veeva QMS is preferred, if not with experience in similar eQMS
• Experience with Risk Management and Risk tools
• Experience with large stakeholder management and metrics reporting to senior management teams

Key competencies/skills/traits/personality:

You are an outreaching and pragmatic person with an open and communicative approach, who has the ability to work effectively with employees at all levels. Flexibility, persistence, and resourcefulness are skills that are highly appreciated and sought at Ascendis. Finally, the ability to embrace the Ascendis systems, while contributing with value-adding experiences from previous positions, will ensure a good match for both parties.

Communication is very important in a virtual company such as Ascendis Pharma. You are proficient in English at a professional level, both written and spoken. You have excellent presentation skills and are familiar with presenting- and communicating to both authorities and to stakeholders, at all levels and functions of the company.

As a person, you are meticulous with an appropriate level of attention to details. You are self-motivated and able to work independently. You appreciate the importance of building relations with colleagues throughout the company, preferably by face-to-face cooperation and -communication, when possible.

Travel: 10-20 days per year.

Office: Denmark, Tuborg Boulevard 12, 2900 Hellerup.

Applications must be submitted in English and will be treated confidentially.