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. 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. /ph3Job Purpose /h3pThe 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. /ph3Key Responsibilities /h3ollibProcess Ownership /bulliDevelop, maintain and continuously improve governing procedures, standards, guidance documents and training material. /liliEnsure processes remain compliant with applicable GxP regulations and industry expectations. /liliDefine process governance, workflows, decision-making models and escalation pathways. /liliLead periodic process reviews and effectiveness assessments. /liliEnsure inspection readiness of all assigned processes. /li /ul /lilibDeviation Management /bulliOwn the global deviation management process. /liliEstablish standards for investigation quality, root cause analysis and effectiveness verification. /liliMonitor quality and timeliness of deviation closure. /liliFacilitate escalation of critical and recurring issues. /liliIdentify systemic trends and recurring failure modes. /liliPartner with business stakeholders to ensure sustainable corrective actions. /li /ul /lilibChange Control Management /bulliOwn the global change control process. /liliEnsure robust impact assessments and risk evaluations are performed. /liliDrive effective planning, implementation and closure of quality-related changes. /liliMonitor change control backlog, overdue records and implementation effectiveness. /liliDrive simplification and optimization opportunities within the change management framework. /li /ul /lilibContinuous Improvement /bulliDrive initiatives that improve efficiency, effectiveness and user experience of the QMS. /liliFacilitate problem-solving and process enhancement activities. /liliPromote a culture of proactive quality and operational excellence. /liliImplement lessons learned from inspections, audits, deviations, metrics and feedback. /liliSupport digital transformation initiatives related to quality processes and systems. /li /ul /lilibQuality Intelligence /bulliEstablish and maintain the Quality Intelligence framework. /liliMonitor emerging regulatory expectations, inspection trends and industry best practices. /liliTranslate external intelligence into actionable business insights. /liliIdentify quality risks and opportunities through data analysis. /liliCollaborate with Regulatory Intelligence and subject matter experts to assess potential impacts on the QMS. /li /ul /lilibMetrics, Analytics Management Review /bulliDefine and maintain KPIs and KQIs for assigned processes. /liliMonitor process health, compliance performance and effectiveness. /liliAnalyze trends and identify areas requiring management attention. /liliProvide input to Quality Management Review activities. /liliSupports development of dashboards and reporting that enable data-driven decision making. /li /ul /lilibStakeholder Engagement /bulliAct as subject matter expert for assigned processes. /liliProvide coaching, guidance and training to process users. /liliSupport inspections, audits and health authority interactions. /liliBuild strong partnerships across the organization to ensure effective implementation of quality processes. /li /ul /li /olh3Qualifications /h3pbEducation /b; Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Enginee