Ass. Director GPS Quality Management

argenx

12d•Remote

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. PURPOSE OF THE FUNCTION 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

Requirements

At least Bachelor’s degree in pharmacy, nursing, healthcare or other life-science or technical field or country equivalent combination of education and experience
At least 10 years of experience in the pharmaceutical/biotech industry with at least 5 years in relevant pharmacovigilance/drug safety field
Proven track record of establishing or managing pharmacovigilance quality systems, processes and teams
Robust experience with preparing for, hosting and responding to audits and regulatory inspections globally
Solid working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
Expert knowledge of GXP quality and compliance requirements, processes and measures.
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 skills with the ability to communicate complex issues clearly.
Demonstrated ability to author and contribute to procedural documents.
Ability to motivate, influence, and collaborate with multidisciplinary teams.
Professional level computer skills, including proficiency with tracking systems, presentation software.
Fluency in written and spoken English.

Responsibilities

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 escalate 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