Clinical Quality Lead

at  Argenx

SKILLS AND COMPETENCIES

• Experience in Quality Oversight for Externally Sponsor Research, Non-interventional studies, Early Access Programs, Name Patient Programs and other non traditional clinical studies
• In‐depth knowledge of all Clinical Trial related FDA and EU regulations and ICH Guidelines.
• Ability to create a comprehensive study quality oversight plan and audit program and lead the execution thereof.
• Stakeholder management skills

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Minimum 7 years clinical trial experience
• Minimum 5 years quality assurance experience
• FDA, EMA, MHRA, PDMA Inspection experience
• Capable of building effective relationships with internal and external stakeholders.
• Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timeline
• Life science educational background
• Fluent in English

PURPOSE OF THE FUNCTION

• Act as the quality lead for all Externally Sponsor Research, Non-interventional studies, Early Access Programs, Name Patient Programs and other non traditional clinical studies
• Drive towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing
• Support the Clinical Quality Vendor Lead to ensure harmonized quality vendor oversight

ROLES AND RESPONSIBILITIES

• Serve as primary Quality point of contact for Externally Sponsor Research, Non-interventional studies, Early Access Programs, Name Patient Programs and other non traditional clinical studies
• Be the Quality point of contact for Global Medical Affairs
• Lead the GCP quality oversight for assigned trials, collaborating closely with trial teams to uphold high-quality standards
• Oversee the clinical trial audit programs, including leading the audit site selection process for study-specific audit plans in collaboration with CTT(s), and ensuring timely audit conduct, reporting, review, and closeout in accordance with argenx processes
• Work with Trial Team to produce GCP quality system metrics for real-time quality monitoring and reporting (e.g., audits, deviations, CAPAs), and conduct trend analysis for management reporting
• Drive the investigation of trial quality events and define necessary corrective and preventive measures
• Lead clinical trial inspection readiness activities to ensure preparedness
• Provide QA input during the creation/revision of argenx clinical procedural documents for GCP compliance
• Oversee the relationship and performance of clinical partners/vendors to maintain quality standards (incl. vendor qualification)