Gxp System And Process Manager

GxP System and Process Manager page is loaded GxP System and Process Manager Apply locations Ferring Denmark Copenhagen, Denmark time type Full time posted on Posted 4 Days Ago job requisition id R0029559 Job Description:

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 + You
You 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 Ferring
As 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 you
We 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 you
If 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 NørskovNielsen, at +4528787354.

Location:
Ferring Denmark Supporting our employees' family building journeys

At Ferring, we’re committed to advocating everyone’s right to build a family. That’s why we’re launching our most inclusive and comprehensive family building benefits package yet.

The package recognises the complexities of building a family and aims to remove financial barriers associated with fertility treatment and family building options, by providing financial support and a global minimum standard of 26-weeks of paid parental leave. We’ll offer support for fertility treatments, surrogacy programmes, adoption, egg freezing, counselling and related services, as well as paid leave for fertility treatment and adoption procedures.

Ferring Project Family

At Ferring, we believe in everyone’s right to a family and we commit to building families of every shape and size.
Millions of people around the world are unable to access the care, treatment and support they need to build a family. We want to change that.
We are addressing some of the greatest challenges in reproductive medicine and maternal health through our research and development programmes.
Learn more about our #FamilyProject Commitment

Driven by its entrepreneurial spirit and enabled by a decentralised organisational setup, Ferring will harness its world-class competencies in science and business with other innovative technologies to create solutions for patients and doctors.
By developing an understanding of people’s needs, we will deliver personalised healthcare solutions, integrating pharmaceutical products with diagnostics, data, devices, education and support services to optimise health outcomes.
Ferring will be the world-leading, most trusted healthcare company in reproductive medicine and maternal health, and a leader in specialty areas within gastroenterology and urology. Each of us at Ferring will contribute to providing innovative solutions to help people live better lives. We will devote significant research and development investment to new therapeutics, life cycle management and next generation healthcare solutions.
As a privately owned, specialty healthcare company that operates globally, Ferring will grow revenues at a rate that is 50% faster than the industry average. We will strive for efficiencies in our business and create flexibility to invest in opportunities to build our future.
We are, and continue to be, part of a transparent and aligned company. We strive to best address the needs of patients, stakeholders and customers by collaborating across functions, experimenting and sharing our practices, and continuously learning. We are always guided by the Ferring Philosophy.

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