Quality Compliance Lead

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

Job Purpose

The Quality Compliance Lead is responsible for ensuring the effectiveness, compliance, and continuous improvement of key Quality Management System (QMS) processes. The role serves as global process owner for Deviations, Change Controls, Continuous Improvement, and Quality Intelligence, ensuring these processes are compliant, inspection-ready, data-driven, and support business objectives. The Quality Compliance Lead drives a proactive quality culture through the identification of quality risks, process performance trends, regulatory expectations, and improvement opportunities. The role partners with stakeholders across Quality, Clinical, Regulatory, Manufacturing, Supply Chain, Pharmacovigilance, and other business functions to strengthen quality oversight and operational excellence. This role aligns with responsibilities already applied within argenx quality compliance activities, including ownership of deviation and change control processes, driving continuous improvement initiatives, monitoring external regulatory developments, and establishing quality metrics and KPIs.

Key Responsibilities

1. Process Ownership
   • Develop, maintain and continuously improve governing procedures, standards, guidance documents and training material.
   • Ensure processes remain compliant with applicable GxP regulations and industry expectations.
   • Define process governance, workflows, decision-making models and escalation pathways.
   • Lead periodic process reviews and effectiveness assessments.
   • Ensure inspection readiness of all assigned processes.
2. Deviation Management
   • Own the global deviation management process.
   • Establish standards for investigation quality, root cause analysis and effectiveness verification.
   • Monitor quality and timeliness of deviation closure.
   • Facilitate escalation of critical and recurring issues.
   • Identify systemic trends and recurring failure modes.
   • Partner with business stakeholders to ensure sustainable corrective actions.
3. Change Control Management
   • Own the global change control process.
   • Ensure robust impact assessments and risk evaluations are performed.
   • Drive effective planning, implementation and closure of quality-related changes.
   • Monitor change control backlog, overdue records and implementation effectiveness.
   • Drive simplification and optimization opportunities within the change management framework.
4. Continuous Improvement
   • Drive initiatives that improve efficiency, effectiveness and user experience of the QMS.
   • Facilitate problem-solving and process enhancement activities.
   • Promote a culture of proactive quality and operational excellence.
   • Implement lessons learned from inspections, audits, deviations, metrics and feedback.
   • Support digital transformation initiatives related to quality processes and systems.
5. Quality Intelligence
   • Establish and maintain the Quality Intelligence framework.
   • Monitor emerging regulatory expectations, inspection trends and industry best practices.
   • Translate external intelligence into actionable business insights.
   • Identify quality risks and opportunities through data analysis.
   • Collaborate with Regulatory Intelligence and subject matter experts to assess potential impacts on the QMS.
6. Metrics, Analytics & Management Review
   • Define and maintain KPIs and KQIs for assigned processes.
   • Monitor process health, compliance performance and effectiveness.
   • Analyze trends and identify areas requiring management attention.
   • Provide input to Quality Management Review activities.
   • Supports development of dashboards and reporting that enable data-driven decision making.
7. Stakeholder Engagement
   • Act as subject matter expert for assigned processes.
   • Provide coaching, guidance and training to process users.
   • Support inspections, audits and health authority interactions.
   • Build strong partnerships across the organization to ensur