Ass. Director GPS Quality Management

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 Global Patient Safety (GPS) Quality Management (QM) Lead is responsible for the operational implementation of the Pharmacovigilance (PV) Quality Management System (QMS) in a consistent, effective and efficient way within the Global Patient Safety functional area.
• Provide pharmacovigilance (PV) oversight for the management and operational maintenance of third-party contractual obligations.
• This position will also:

• Drive the growth of the GPS Quality Management function.
• Drive & Implement the Comprehensive Training Program.
• Manage GPS Procedural Document activities
• Actively participate in and coordinate GPS Audit & Inspection Readiness, Support & Management.
• Drive GPS Continuous Improvement (Issue Management, Process improvement, KPI development).
• Support and or manage the development and compliance monitoring of the pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners
• Support, guide, and delegate GPS QM activities to other GPS QM team members as appropriate in collaboration with the Director, GPS Quality Management

Reporting line:
Director, GPS Quality Management

• Coordinate and manage GVP Audit & Inspection activities
• Actively engage in internal global GVP audit program and inspection readiness activities in collaboration with the argenx Quality functional area.
• Prepare GPS team members on inspection readiness activities.
• Ensure appropriate documents are readily retrievable to use during an Inspection (GPS inspection slides, CVs, JDs, PVAs are contact information is updated and readily available).
• Coordinate and prepare the GPS responses to audit and inspection findings.

• Assess GPS issue management trends and develop / implement actions plans to mitigate systemic causes.
• Identify internal deviations and lead GPS team in determining corrective and preventive actions.
• Guide the GPS team to determine root cause of issue to avoid recurrence.
• In collaboration with the argenx Quality functional area, lead the implementation of corrective or preventive actions.

• Develop and implement the Pharmacovigilance training program.
• Develop, expand, and deliver the pharmacovigilance training program (procedural documents, inspection readiness, refresher training, etc).
• Work closely with key stakeholders to support and/or implement pharmacovigilance training across the organization.
• Coordinate the monitoring, maintaining, re-evaluating and updating the GPS training curricula
• Provide training to relevant argenx employees and 3rd parties (when applicable)
• Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS processes & procedures.
• Proactively engage in cross functional Procedural Document activities/forums to determine relevance to GPS and assure appropriate GPS input and review are provided.
• Support document control through use of Veeva System.
• Resolve vendor questions and elevate issues to relevant GPS staff as appropriate.

• Coordinate development & subsequent evaluation of Key Performance Indicators and adapt them to reflect the evolving business needs.
• Monitor compliance to 3rd party contractual obligations/PVAs and determine if there are gaps or non-conformities and report appropriately into GPS staff
• Liaise with the QA Department regarding GPS quality & compliance requirements/deliverables.
• Monitor the status of and compliance with GPS Standard Operating Procedures (SOPs) and other controlled documents.
• Coordinate the development and compliance monitoring of the pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners

• Perform other tasks and duties as assigned by line manager or GPS Leadership

• Excellent planning and organizational skills.
• Excellent oral and written communication skills.
• Ability to work in global environment.
• Solution oriented with ability to prioritize and work independently.
• Excellent presentation…