GPS Quality Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $128k - $176k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🧬 Biotechnology

Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• 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 • Engage in internal global GVP audit program and inspection readiness activities • Prepare GPS team members on inspection readiness activities • Assess GPS issue management trends and develop/implement actions plans to mitigate systemic causes • Guide the GPS team to determine root cause of issues to avoid recurrence • Develop, expand, and deliver the pharmacovigilance training program • Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS processes & procedures.

🎯 Requirements

• At least Bachelor’s degree in pharmacy, nursing, healthcare or other life-science or technical field • 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 • 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.

🏖️ Benefits

• Comprehensive benefits package, including health benefits • Retirement savings plans • Short-term and long-term incentive programs