GxP System and Process Manager

GxP System & Process Manager in Regulatory Affairs

Do you want to expand your experience with operating IT systems in a GxP regulated framework within the area of Regulatory Affairs? And are you motivated by supporting colleagues and exploring how to optimise systems and tools to meet business requirements?

In the Global Regulatory Operations & Compliance department at Ferring we deliver regulatory data, documents, submissions and IT system operations to the Global Regulatory Affairs community.

We are looking for a new colleague to join us in a position as GxP System & Process Manager.

Our new colleague will drive business system operational activities for the Regulatory Affairs IT Systems used globally at Ferring - ensuring inspection ready systems and support of the business processes for document management, submission management and regulatory information management.

Ferring + YouYou will join a team of 7 dedicated and experienced colleagues with different backgrounds and expertise areas. The team collaborates closely on delivering efficient user support, system maintenance, submission ready documentation and training. The team is also a stakeholder in process and system implementation and upgrade projects.

Your day at FerringAs our new GxP System & Process Manager your workday will contain activities like

• Trouble-shoot issues and reply to questions from the user community, using your technical expertise combined with your end-to-end business process understanding

• Review and manage system access requests

• Maintain system documentation

• Evaluate, plan and implement configuration and data change requests

• Participate in system development projects

• Support data reporting requests

• Ensure system inspection readiness in collaboration with your team

You will be working in a multicultural and interdisciplinary environment as your colleagues and the user community are located throughout the global Ferring organisation.

Behind our innovation… There’s youWe are looking for a profile who is technically savvy and has experience with setup, maintenance and validation of regulated IT systems. You hold a Master degree or bachelor, preferably with 2+ years’ experience from the pharmaceutical industry.

Fluency in English and excellent verbal and written communication skills are essential.

Most importantly, you are organised, self-motivated and detail-oriented, and you make a point of delivering high-quality work and meeting your deadlines.You are a pro-active and reliable team player who values collaboration and supporting colleagues in completing activities accurately and efficiently.

Behind our purpose… there’s youIf our mission and your vision are aligned, please apply. Kindly include a few lines regarding your motivation for applying in the CV or a cover letter. Please note that we review applications continuously and close the process when we find the right match.

Your primary work location will be the spectacular and state-of-the-art new domicile Soundport near Copenhagen Airport. We are unable to offer relocation assistance for this position. Candidates must be located in the Øresund region or willing to relocate at their own expense.

If you have any questions, you are very welcome to contact Associate Director, GxP Systems & Processes, Anne Nørskov Nielsen, at +4528787354.

Location:
Ferring Denmark