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.

To strengthen our Business Information Systems team, based in Ghent, Belgium, we are looking for a talented individual to fill the position of BIS Operations Data and AI Lead.

About The Role:

To strengthen our BIS team, we are seeking a talented and experienced BIS Operations Data and AI Lead specializing in Generative AI (GenAI) and Data Analytics. This role holds global responsibility for ensuring the compliant, resilient, and secure operation of BIS systems that support GenAI and Data Analytics processes. The position also involves ensuring seamless and secure integrations with regulators, internal and external stakeholders, and partners across the organization.

The scope of responsibility extends across all functional teams within the Drug Development Quality (DDQ) domain and other relevant global teams. Given the nature of these systems, compliance with GxP regulations is mandatory, requiring adherence to stringent regulatory standards, audits, and inspections.

What You’ll Do – Key Responsibilities

• Leadership, Collaboration & Stakeholder Engagement:
  • Manage the Global AI & Data Analytics community support team.
  • Partner closely with internal and external stakeholders to understand, anticipate, and influence business needs.
  • Translate business requirements into efficient, harmonized, and scalable solutions.
  • Act as a liaison between BIS, DDQ leadership, and external partners to ensure alignment with business objectives.
• Technical Expertise & Support:
  • Provide in-depth technical expertise on GenAI and Data Analytics applications, such as Co-Pilot, ChatBots, WalkMe, Snowflake, and Matillion.
  • Ensure robust system integrations using technologies like REST API, Postman, and VQL, ensuring seamless data flow and compliance.
• Operational Excellence & Continuous Improvement:
  • Oversee system lifecycle management, ensuring that all GenAI and Data Analytics tools remain compliant and secure.
  • Establish KPIs and operational objectives to measure performance and effectiveness.
  • Identify opportunities for automation, process optimization, and AI-driven insights.
  • Lead and support change management initiatives to enhance the efficiency of GenAI and Data Analytics processes.
• Compliance & Governance:
  • Maintain compliance with GxP regulations, audits, and inspections for all BIS systems.
  • Ensure systems meet validation and documentation requirements, maintaining audit readiness.
  • Provide guidance on system administration, access management, and security best practices.
• Vendor & External Partner Coordination:
  • Oversee and coordinate with external vendors and service providers, ensuring timely and high-quality delivery of support services.
  • Conduct vendor service reviews to ensure alignment with contractual obligations and business needs.
• Incident & Request Management:
  • Act as an escalation point for system-related incidents, ensuring prompt resolution.
  • Oversee service desk handover processes, ensuring knowledge transfer and effective troubleshooting.
  • Manage requests, incidents, and system changes, maintaining structured documentation.

Required Qualifications & Experience

• Education:
  • Bachelor's or Master’s degree in Information Technology, Computer Science, Data Analytics, or a related field.
• Professional Experience:
  • Minimum of 5+ years of IT experience, preferably within a global pharmaceutical or other regulated industry.
  • Strong understanding of GenAI, Data Analytics, and their applications in the pharmaceutical and life sciences sectors.
  • Experience in system administration of cloud-based (SaaS) applications.
  • In-depth knowledge of data flow, data mapping, and data lake technologies (e.g., Snowflake, Databricks, Alation, Collibra).
• Technical Skills:
  • Proficiency in REST API integration and application development.
  • Hands-on experience with Java, JavaScript, SQL, XML, HTML, Postman, Curl.
  • Strong competency in Microsoft Office Suite, Oracle, SQL Server, PDF tools, and operating systems (Windows).
• Project Management & Soft Skills:
  • Strong project execution skills, ensuring projects are delivered on time and within budget.
  • Ability to manage multiple projects simultaneously in a fast-paced environment.
  • Excellent communication and stakeholder engagement skills.
  • Ability to drive innovation and digital transformation initiatives within the organization.
• Cultural Alignment: Demonstrated commitment to the argenx cultural pillars:
  • Innovation: A passion for innovation and a track record of driving innovative solutions
  • Co-Creation: Ability to foster collaboration and leverage the collective power of the team
  • Empowerment: Commitment to empowering team members and promoting a culture of trust and accountability
  • Excellence: Dedication to maintaining a quality culture and prioritizing patient safety
  • Humility: Ability to handle successes and challenges gracefully and learn from both