Bis Quality Business Analyst - Gent, België - Argenx

Argenx

Geverifieerd bedrijf

Gent, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer.

Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx is translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.

argenx's first experimental medicine, efgartigimod, is being evaluated in multiple autoimmune diseases, including myasthenia gravis (MG), pemphigus vulgaris (PV), immune thrombocytopenia (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

argenx is located in Ghent, Belgium, Boston, Massachusetts and Tokyo, Japan.

Scope of the job

As the liaison between BIS team(s) for the Quality area and the Quality Business function, the role entails creating, developing, overseeing, organizing, storing, and analyzing data and processes within the Quality area.

Role

Obtain a deep understanding of relevant business area(s) to be able to recommend solutions and build highquality requirements
Collaborate with BIS Managers on roadmap planning and prioritization
Gather business requirements using common techniques such as:
Interviews
Questionnaires
Prototyping
Document Analysis
Brainstorming
Identify specific business opportunities. Shape business requirements by making recommendations and challenging them by suggesting alternatives to proposed solutions.
Formulate techniques for defining processes and quality data collection to ensure adequacy, accuracy and legitimacy of data
Help improve the quality of IT services by analysing the core business needs
Understand technical options, limitations, costs, and risks. Communicate tradeoffs to business partners and work with them to shape requirements accordingly
Translate conceptual user requirements into precise, detailed functional requirements
Work with business stakeholders and delivery teams (internal or external) to prioritize requirements
Help resolve competing priorities between stakeholder groups facilitatig discussions. Facilitate escalation of issues where appropriate.
Create artifacts as appropriate, including business case documentation, scope documentation, and process flows
Support delivery teams as they develop, test, and deploy solutions. Review delivery team output to ensure requirements are correctly met
Define and participate in user acceptance testing process
Document current processes and models to understand inefficiencies or gaps. Identify automation opportunities. Act as a liaison between the solution provider and the business
Propose and promote a strategy to rationalize the existing platforms

Job requirements

Good Understanding of Quality area, data and processes where quality is a key contributor or owner within (Bio)pharmaceutical company
Good Understanding of Quality organisation
A Bachelor's degree or equivalent combination of education and experience
Minimum 5 years of relevant experience in Biopharmaceutical Development functions
Digital background preferably in a pharmaceutical environment
Proven ability to work in a highly regulated environment
Experience with
CSV
Quality Management System
Knowledge of new technologies (e.g. RPA, AI, Advanced analytics,...)
Data Management, Data integration
Quality platforms, preferably Veeva
Ability to quickly learn the objectives, structures, operations, and policies of a new business area
Strong problem resolution, negotiation, and influencing skills
Demonstrated ability to engage delivery team and business partners to achieve target outcomes
Proven interpersonal skills and an ability to influence senior leaders and peers
Demonstrated ability to communicate complex technical information in a simplified manner to various stakeholders verbally and in writing
Experience creating documentation such as business case documentation or business requirements summaries
Experience with