Global Quality Compliance Leader - Deviation & Change Control

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

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.