Bis Quality Business Analyst
Il y a 2 mois
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 high-quality 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 trade-offs 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 agile development methodologies and agile planning tools
- Experience in translating business requirements in high quality documentation in a CSV framework
**Offer**:
- A competitive salary package with extensive benefits.
- A work environment in a successful, dynamic, rapidly growing biotech company.
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