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IT Validation Manager for our Dynamics 365 and financial solutions

ascendis-pharma · 30+ days ago
Negotiable
Full-time
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Do you have a Quality mindset? Are you passionate about GxP validation?
Do you want to make a difference in the way we work with compliance documentation, data integrity and test automation in the pharmaceutical industry?

Now is your chance to join the growth journey in Ascendis Pharma as our new IT Validation Manager

Ascendis Pharma is a fast-growing global biopharmaceutical company; you will be based in our headquarters in Hellerup, together with the rest of the Finance and Operations IT product team.

We apply our trademark 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. 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 product team.
In our Global IT product teams, we apply agile principles to ensure quality, flexibility, and efficiency.

As a key member of the team, you will play a crucial role in planning and executing GxP validation activities. You will develop and implement the structure and processes required to provide robust traceability.

This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams - working together to achieve extraordinary results.

As IT Validation Manager, you will join the Product Team supporting our Finance and Product Supply business functions, mainly through our Microsoft Dynamics 365FO platform.

In Ascendis Pharma we are a cloud-first, zero legacy system environment. You will have excellent development opportunities in a very flexible environment where “the way we do things here” is open for discussion.

Your key responsibilities will be to:

  • Own the GxP validation and quality deliverables for the Microsoft Dynamics 365 Finance & Operations processes and system, including oversight and planning of all related activities. 
  • Manage the assessment of technology solutions and vendors to ensure adherence to software development best practices.
  • Influence, develop and maintain the test strategy to ensure the system is validated against user, functional and design requirements.
  • Evaluate changes to define the level of validation required in coordination with IT QA and Compliance to ensure that we remain in control and that the system remains fit for intended use.
  • Ensure team focus on quality deliverables.
  • Deliver according to Ascendis Pharma’s Quality Management System and ensure timely initiation and closeout of all quality events (changes, deviations and CAPAs).
  • Ensure communication, documentation and coordination of risks, validation, and test activities.

 

Qualifications and Skills:

You hold a relevant academic degree – preferably a Master 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 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 planning and execution.
  • Preferably knowledge of Microsoft D365 Finance & Operations or other Enterprise Resource Planning platform
  • Business process knowledge within product supply: logistics, supply chain or QA
  • 5 years of validation-related discipline experience in the pharmaceutical or medical device industry
  • Great stakeholder competences and communication skills

Key competencies:

As a person you are self-driven and ready to take responsibility from day one. You are agile at heart; your approach is entrepreneurial and you enjoy finding simple solutions to complex scenarios.

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.  

You think on your feet and keep your composure when things move quickly.

Last but not least, you have a good sense of humor and enjoy working across functions and cultures.

You are proficient in English at a professional level, both written and spoken.

 To succeed in this role, we also expect you to be:

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

We offer an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues on advancing an exciting product pipeline.

Travel: approx.10 days per year.

Office: Ascendis Pharma Headquarter, Hellerup 

Applications will be evaluated when received, so please apply as soon as possible.

All applications must be submitted in English and are treated confidentially.

 

If you want to know more about the position or the company, please contact Product Owner Mikkel Lund on mobile: +45 4268 3550 or email: milu@ascendispharma.com, or People Leader Lene Larsen on mobile: +45 22995471 email: lrl@ascendispharma.com or visit out website www.ascendispharma.com

 

Benefits

  • You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
  • To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. We find a way to help you grow.
  • Ascendis Pharma headquarters resides in a modern and bright office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
  • To ensure a balanced approach to the office, employees can work from home up to two days per week.
  • Laptop, iPhone, paid internet, and home office equipment
  • A thorough and structured onboarding program
  • Soft drinks, fresh fruit, and lunch every day in our canteen.

Last updated on Nov 23, 2023

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