Quality Compliance Lead

pJoin 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. /p pWe 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. /p h3Job Purpose /h3 pThe 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. /p pThe 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. /p pThis 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. /p h3Key Responsibilities /h3 ul liProcess Ownership /li /ul h3Serve As Global Process Owner For /h3 ul liDeviations /li liChange Controls /li liContinuous Improvement /li liQuality Intelligence /li /ul h3Responsibilities Include /h3 ul liDevelop, maintain and continuously improve governing procedures, standards, guidance documents and training material. /li liEnsure processes remain compliant with applicable GxP regulations and industry expectations. /li liDefine process governance, workflows, decision‑making models and escalation pathways. /li liLead periodic process reviews and effectiveness assessments. /li liEnsure inspection readiness of all assigned processes. /li liDeviation Management /li liOwn the global deviation management process. /li liEstablish standards for investigation quality, root cause analysis and effectiveness verification. /li liMonitor quality and timeliness of deviation closure. /li liFacilitate escalation of critical and recurring issues. /li liIdentify systemic trends and recurring failure modes. /li liPartner with business stakeholders to ensure sustainable corrective actions. /li liChange Control Management /li liOwn the global change control process. /li liEnsure robust impact assessments and risk evaluations are performed. /li liDrive effective planning, implementation and closure of quality‑related changes. /li liMonitor change control backlog, overdue records and implementation effectiveness. /li liDrive simplification and optimization opportunities within the change management framework. /li liContinuous Improvement /li liDrive initiatives that improve efficiency, effectiveness and user experience of the QMS. /li liFacilitate problem‑solving and process enhancement activities. /li liPromote a culture of proactive quality and operational excellence. /li liImplement lessons learned from inspections, audits, deviations, metrics and feedback. /li liSupport digital transformation initiatives related to quality processes and systems. /li liQuality Intelligence /li liEstablish and maintain the Quality Intelligence framework. /li liMonitor emerging regulatory expectations, inspection trends and industry best practices. /li liTranslate external intelligence into actionable business insights. /li liIdentify quality risks and opportunities through data analysis. /li liCollaborate with Regulatory Intelligence and subject matter experts to assess potential impacts on the QMS. /li liMetrics, Analytics Management Review /li liDefine and maintain KPIs and KQIs for assigned processes. /li liMonitor process health, compliance performance and effectiveness. /li liAnalyze trends and identify areas requiring management attention. /li liProvide input to Quality Management Review activities. /li liSupports development of dashboards and reporting that enable data‑driven decision making. /li liStakeholder Engagement /li liAct as subject matter expert for assigned processes. /li liProvide coaching, guidance and training to process users. /li liSupport inspections, audits and health authority interactions. /li liBuild strong partnerships across the organization to ensure