IT System Manager, Regulatory, QA, Pharmacovigilance
Ascendis Pharma, Denmark

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Aug 30, 2021
Last Date
Sep 30, 2021
Location(s)

Job Description

Do you get excited about making good applications even better? Are you equally skilled in understanding application configuration as well as business processes?

Join a fast-growing biotech company in a role, where you will work in an agile team supporting freshly implemented key business applications.

Ascendis Pharma, a visionary and ambitious company, offers you an opportunity to become involved in the development of ground-breaking therapies in a clinical setting.

As IT System Manager, you will be the expert in the applications your team supports. You will be a part of understanding how business requirements translate to configuration changes, and then ensuring the deployment, validation, and documentation of the changes. You will ensure that the end-users get the training and support they need to get most out of the applications. It will also be a part of your role to maintain a close relationship with the application vendors and understand which new features may benefit the business.

You will join Ascendis Pharma and the Product Team in Global IT that supports our Regulatory, Quality and Pharmacovigilance business function.

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. We are currently on a journey to implement agile methodology and a product-mindset in the ways we work.

Your main responsibilities are:

  • Responsible for maintaining and improving applications, including regulatory compliance (GxP)
  • Ensure understanding of business processes and requirements, and translating these to technical requirements for the vendors to implement
  • Work with the other members on the team to develop application roadmaps aligned with business and IT goals
  • Coordinate with cross-functional stakeholders such as IT infrastructure, QA, Software vendors, support partners to ensure efficient delivery of applications changes
  • Responsible for system administration and technical support, for instance resolving access request and incidents
  • Develop training material and ensure well-trained user base
  • Conduct periodic reviews to ensure compliance to GxP regulation
  • Develop application documentation as per SDLC methodology and operational documentation such as SOPs, work instructions and user manuals
  • Manage and maintain oversight over maintenance and support partners

The successful candidate has 5+ years of experience as a system manager, application analyst, solution architect, validation manager or something completely different. Ideally you have worked in a biotech, pharmaceutical company or consultancy catering to the pharmaceutical industry. You have:

  • A Master’s degree in a relevant field
  • Experience with maintaining applications from Quality, Regulatory and Pharmacovigilance, such as the Veeva RIM and Quality Vaults or Argus
  • Deep business process knowledge in either Quality, Regulatory or Pharmacovigilance
  • Strong configuration skills
  • Extensive experience with GxP validation such as 21 CFR Part 11 and GAMP5
  • Experience defending application validation documentation in front of inspectors from Regulatory Authorities
  • Ideally knowledge about, but surely an interest in agile methodology

As a person you are self-driven and ready to take responsibility from day one. You are agile at heart and more concerned about the results of your team than your individual success. Your approach is entrepreneurial and you enjoy finding solutions that meet the business needs. You think on your feet and keep your composure when things move quickly.

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

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

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.

Travelling: Approx. 20-30 days/year


Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea. We also have facilities in Heidelberg, Germany, as well as Princeton and Palo Alto, U.S.A. . Your international mindset and virtual presence is important to our global community.

If you want to know more about the position, please contact Ivanna Rosendal on M +45 21 76 76 99 or . A

Job Specification

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Ascendis Pharma

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