Career Opportunities in the Foresite Capital Network

Are you passionate about validation and test planning and automation? Do you have experience within Agile development and delivery around Microsoft D365 Finance & Operations in the pharmaceutical industry?

If so, now is your chance to join Ascendis Pharma as our new IT Validation Manager for our D365 product team.

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.

We are seeking a passionate IT Validation Manager to join our Finance and Product supply IT product team. As a key member of the team, you will play a crucial role in planning and executing validation activities and also participate in test planning and release management. Global IT work after agile principles in the product team and you can expect there will be opportunities to develop your capabilities and act in different team roles as needed – i.e., release management. 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 Global IT organization, and report directly to Lene Larsen, People Leader in Global IT, and have a functional reference to Sune Mejlvang, IT Business Partner. You will be based in our headquarter in Hellerup, together with the rest of the product team.

Your key responsibilities will be:

• To own the compliance and quality deliverables for the D365 system and ensure oversight and planning of all related activities.
• Responsible for the assessment of technology solutions and vendors to ensure adherence to software development best practices.
• Influence developing and maintaining the test strategy to ensure the system is evaluated against user, functional and design requirements.
• Evaluate updates to define the level of validation required in coordination with IT Compliance and QA IT to ensure the system remains fit for intended use.
• Ensure the team focus on the right deliverables and have the quality set at the right level.
• Deliver according to Ascendis Pharma’s Quality Management System and ensure timely initiation and closeout of all quality events (deviations, CAPAs and changes).
• Ensure communication and coordination of risks, validation, and test activities.

Qualifications and Skills:

You hold a relevant academic degree – preferably a bachelor within IT, Production, pharma or something completely different with relevance to GxP validation and IT solution – and 5 years of experience within pharma and validation and test management. It will be an advantage if you have a Test manager certificate and an Agile certification and/or experience from an agile setup.

Furthermore, you have:

• A structured and pragmatic approach to Governance, Risk Management and new technologies
• A quality mindset aspiring to become a validation expert with a holistic approach to test planning and execution.
• A basic knowledge of Microsoft D365 Finance & Operations
• A knowledge of one or more of the process areas finance or product supply
• 5 years of validation-related discipline experience in the pharmaceutical or medical device industry
• Great stakeholder competences and communication skills

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

• be familiar with the challenges of working in a regulated environment.
• Be familiar with agile operations and development methods.
• Be familiar with Azure DevOps or similar lifecycle management system.
• Have strong communication skills for engaging with all levels within the organization.

Travel: approx.10 days per year.

Office: Ascendis Pharma Headquarter, 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.