{"id":1588431,"url":"https://alion.io/job/argenx-quality-compliance-lead","title":"Quality Compliance Lead","company":{"id":1805561,"name":"argenx","domain":"argenx.com","url":"https://alion.io/company/argenx","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":77,"open_postings":14,"ghost_share":0,"stale_share":0.929,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-10-19T05:45:15Z"}},"role":"Legal","role_family":"Legal","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Ghent, Belgium"],"countries":["BE"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":89600,"max":123200,"currency":"EUR","period":"year","gross":null,"usd_annual":139189},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-01T15:27:49Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-19T15:42:06Z","board_verified":true,"closed_at":null,"days_open":18,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":18},"description":"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.\nWe 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.\nJob Purpose\nThe 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\nbusiness objectives.\nThe 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.\nThis 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.\nKey Responsibilities\n1. Process Ownership\nServe as Global Process Owner for:\nDeviations\nChange Controls\nContinuous Improvement\nQuality Intelligence\nResponsibilities include:\nDevelop, maintain and continuously improve governing procedures, standards, guidance documents and training material.\nEnsure processes remain compliant with applicable GxP regulations and industry expectations.\nDefine process governance, workflows, decision-making models and escalation pathways.\nLead periodic process reviews and effectiveness assessments.\nEnsure inspection readiness of all assigned processes.\n2. Deviation Management\nOwn the global deviation management process.\nEstablish standards for investigation quality, root cause analysis and effectiveness verification.\nMonitor quality and timeliness of deviation closure.\nFacilitate escalation of critical and recurring issues.\nIdentify systemic trends and recurring failure modes.\nPartner with business stakeholders to ensure sustainable corrective actions.\n3. Change Control Management\nOwn the global change control process.\nEnsure robust impact assessments and risk evaluations are performed.\nDrive effective planning, implementation and closure of quality-related changes.\nMonitor change control backlog, overdue records and implementation effectiveness.\nDrive simplification and optimization opportunities within the change management framework.\n4. Continuous Improvement\nDrive initiatives that improve efficiency, effectiveness and user experience of the QMS.\nFacilitate problem-solving and process enhancement activities.\nPromote a culture of proactive quality and operational excellence.\nImplement lessons learned from inspections, audits, deviations, metrics and feedback.\nSupport digital transformation initiatives related to quality processes and systems.\n5. Quality Intelligence\nEstablish and maintain the Quality Intelligence framework.\nMonitor emerging regulatory expectations, inspection trends and industry best practices.\nTranslate external intelligence into actionable business insights.\nIdentify quality risks and opportunities through data analysis.\nCollaborate with Regulatory Intelligence and subject matter experts to assess potential impacts on the QMS.\n6. Metrics, Analytics & Management Review\nDefine and maintain KPIs and KQIs for assigned processes.\nMonitor process health, compliance performance and effectiveness.\nAnalyze trends and identify areas requiring management attention.\nProvide input to Quality Management Review activities.\nSupports development of dashboards and reporting that enable data-driven decision making.\n7. Stakeholder Engagement\nAct as subject matter expert for assigned processes.\nProvide coaching, guidance and training to process users.\nSupport inspections, audits and health authority interactions.\nBuild strong partnerships across the organization to ensure effective implementation of quality processes.\nQualifications\nEducation\nBachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, Quality Management, or related discipline.\nExperience\nMinimum 7-10 years of experience in pharmaceutical, biotechnology, medical device or related regulated industry.\nSignificant experience with Quality Management Systems.\nDemonstrated experience in deviation management, change control, CAPA and investigation processes.\nExperience supporting inspections and audits.\nExperience with electronic QMS platforms (e.g., Veeva Vault Quality)\nTechnical Knowledge\nStrong knowledge of:\nEU GMP\nFDA GxP requirements\nICH Q9 Quality Risk Management\nICH Q10 Pharmaceutical Quality System\nData integrity principles\nQuality system governance and process management\nRoot cause analysis methodologies\nContinuous improvement methodologies\nQuality metrics and analytics\nKey Competencies\nStrategic thinking\nProcess ownership mindset\nRegulatory awareness\nData-driven decision making\nContinuous improvement leadership\nStakeholder management\nInfluencing without authority\nProblem solving\nStrong communication and presentation skills\nInspection readiness mindse #LI-Onsite\n\nThe annual base salary hiring range for this position is €89,600.00 - €123,200.00 EUR\n\nThis job is eligible to participate in our short-term and long-term incentives program.\nThe hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.\nAt argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.\nBefore you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at .","description_format":"text","description_chars":7387,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Professional Services"],"lifecycle":[{"event":"open","at":"2026-10-01T15:27:49Z"}],"visa":[],"liveness":{"score":50,"band":"ok","label":"Likely open","p_open":1,"p_active":0.557,"p_room":0.9,"age_days":17,"expected_fill_days":29,"reasons":["conf:21","stale_co","win:mid","comp:brand"],"computed_at":"2026-10-19T05:45:15Z"},"pay":{"stated_usd_annual":139189,"is_top_pay":false},"html_url":"https://alion.io/job/argenx-quality-compliance-lead","json_url":"https://alion.io/job/argenx-quality-compliance-lead.json","meta":{"generated_at":"2026-10-20T00:11:13Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":157,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1805561},"rest":"https://alion.io/mcp/rest/get_company?id=1805561"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fargenx-quality-compliance-lead"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fargenx-quality-compliance-lead"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fargenx-quality-compliance-lead"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/argenx-quality-compliance-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fargenx-quality-compliance-lead"}]}