Clinical Quality Lead

argenx

8d•Onsite

About The Position

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. The Clinical Quality Lead is responsible for driving towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing, by providing GCP oversight for an argenx asset (applicable based on assignment), acting as GCP SME, supporting audit and inspection planning and execution, and manage clinical quality event investigations and remediation. The Clinical Quality Lead will also oversee relationship and performance of clinical partners vendors/suppliers, and act as GCP Quality Point of Contact (POC) for assigned Business Partners.

Requirements

In‐depth knowledge of Clinical Trial related US and EU regulations and ICH GCP Guidelines
Ability to create a comprehensive study quality oversight plan and audit program and lead the execution
Proven capability to establish and maintain effective relationships with both internal and external stakeholders
Demonstrated ability to thrive in a dynamic environment within a rapidly growing biotech company, effectively managing challenging timelines.
Ability to influence without direct leadership: motivate and educate the clinical study team on clinical quality aspects
MS Degree
Minimum 7 years clinical trial experience
Minimum 5 years quality assurance experience
FDA, EMA, MHRA, PDMA Inspection experience

Nice To Haves

Knowledge of global pharmacovigilance regulations

Responsibilities

Serve as the primary Quality point of contact for assigned clinical trials
Guide the Clinical Trial Team (CTT) to ensure clinical trials are conducted in compliance with GCPs, regulatory requirements, and argenx processes
Lead the GCP quality oversight for assigned clinical trials, collaborating closely with CTT(s) to uphold high-quality standards
Manage 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
Oversee or lead the qualification/re-qualification of vendors as necessary
Participate in and lead audits to maintain compliance and quality
Work with CTT(s) 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
When assigned as “QA Approver” in ARGO or PhoeniQS, act as QA approver for GCP area.
Act as a delegate for R&D Quality head for the Document Review Committee (DRC)
Participate/lead in regulatory inspections
Oversee the relationship and performance of clinical partners/vendors to maintain quality standards
Support and own key GCP Quality processes per assignment and offer solutions/improvement from a continuous improvement mindset
Provide metrics and trends for continuous improvement, sharing lessons learned and best practices among other CTT(s).
Ability to mentor junior quality leads upon delegation by the R&D quality head.