Quality Compliance Lead

argenx SE; Oost-Vlaanderen; On-site; EUR 90,000 - 123,000; Full time

Job summary

argenx SE is seeking a Quality Compliance Lead to drive the effectiveness and compliance of the QMS, owning deviations, change controls, continuous improvement, and quality intelligence. You will partner with Quality, Regulatory, Manufacturing, and other functions to strengthen oversight and ensure inspection readiness.

The role requires 7–10 years in a regulated biopharma setting, strong EU GMP and ICH knowledge, and proven leadership in process governance and data-driven decision making.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, Quality Management, or related discipline.
• 7-10 years of experience in pharmaceutical/biotech/regulated industry with QMS experience.
• Experience with deviation management, change control, CAPA, inspections and audits; familiarity with Veeva Vault Quality.

Responsibilities

• Own global deviation management process and ensure quality investigations, root cause analysis and effectiveness verification.
• Own global change control process with robust impact assessments and risk evaluations.
• Drive planning, implementation and closure of quality-related changes; monitor backlog and effectiveness.
• Drive continuous improvement initiatives to enhance QMS efficiency, user experience and performance.
• Establish and maintain the Quality Intelligence framework and translate insights into actions.
• Define and maintain KPIs/KQIs; monitor process health and performance; support management reviews.
• Provide SME coaching and training; support inspections, audits and health authority interactions.
• Collaborate across Quality, Clinical, Regulatory, Manufacturing, Supply Chain and other functions to strengthen quality oversight.

Skills

EU GMP

FDA GxP

ICH Q9

ICH Q10

Data integrity

Quality metrics

Root cause analysis

Process governance

Quality improvement

Stakeholder management

Education

Bachelor's/Master's in Life Sciences

Tools

Veeva Vault Quality

Job 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. 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 ensure effective implementation of quality processes.

Qualifications

Education; Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, Quality Management, or related discipline.

Experience; Minimum 7-10 years of experience in pharmaceutical, biotechnology, medical device or related regulated industry. Significant experience with Quality Management Systems. Demonstrated experience in deviation management, change control, CAPA and investigation processes. Experience supporting inspections and audits. Experience with electronic QMS platforms (e.g., Veeva Vault Quality).

Technical Knowledge; Strong knowledge of: EU GMP; FDA GxP requirements; ICH Q9 Quality Risk Management; ICH Q10 Pharmaceutical Quality System; Data integrity principles; Quality system governance and process management; Root cause analysis methodologies; Continuous improvement methodologies; Quality metrics and analytics.

Key Competencies; Strategic thinking; Process ownership mindset; Regulatory awareness; Data-driven decision making; Continuous improvement leadership; Stakeholder management; Influencing without authority; Problem solving; Strong communication and presentation skills; Inspection readiness mindse

Salary & Benefits

The annual base salary hiring range for this position is €89,600.00 - €123,200.00 EUR. This job is eligible to participate in our short-term and long-term incentives program. The 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.

Equal Opportunity & Inclusion

At 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.

Locations

argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam.

Recruiting Agency Policy

argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and ineligible for payment of referral or other fees.