argenx

GPS Quality Manager

United States - Remote

Sponsorship not specified$128k-$176kDetected 11 days ago

Computer VisionBusiness DevelopmentAuditingProcess ImprovementPharmacovigilanceLeadershipCommunicationCollaborationInternal AuditGxP

About the role

This range reflects our good faith estimate at the time of posting.
This means actual pay may differ from the posted range when justified by these factors.
Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.

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.
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).
Coordinate and manage GVP Audit & Inspection 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).
Support the coordination and preparation of GPS responses to audit &inspection findings.
Assess GPS issue management trends and develop / implement actions plans to mitigate systemic causes.

At least 7 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
Expert knowledge of GXP quality and compliance requirements, processes and measures.
At least Bachelor's degree in pharmacy, nursing, healthcare or other life-science or technical field or country equivalent combination of education and experience
Solid working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)

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.
Professional level computer skills, including proficiency with tracking systems, presentation software.
Fluency in written and spoken English.

The annual base salary hiring range for this position is $128,000.00 - $176,000.00 USD.

Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity.
It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.

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.

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com.
Only inquiries related to an accommodation request will receive a response.

This listing is sourced directly from argenx's careers page and normalized into a canonical job model.