Global PV Quality Lead - Audits, CAPA & Training

Remote Worker LTD.; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Remote Worker LTD. is seeking a Global Patient Safety Quality Management Manager to lead the PV QMS operations worldwide. You will oversee audit readiness, CAPA, training, and document control within GPS, collaborating with global teams.

The role emphasizes driving continuous improvement, KPI development, and successful regulatory interactions across regions, focusing on robust process execution in an office-based setting.

Qualifications

• Bachelor’s degree in pharmacy, nursing, healthcare or life-science field.
• At least 5 years in pharma/biotech with 3+ years in PV/drug safety.
• Experience operating PV quality systems, processes and teams.
• Experience hosting audits and regulatory inspections globally; familiarity with PV regulations (Europe, US, Japan).
• Knowledge of GXP quality and compliance requirements.

Responsibilities

• Support and manage GVP Audit & Inspection activities.
• Prepare GPS team for inspection readiness activities.
• Ensure documents are readily retrievable for inspections (slides, CVs, JDs, PVAs).
• Coordinate GPS responses to audit/inspection findings.
• Develop and monitor KPIs for GPS Quality Management.
• Maintain GPS Procedural Documents and support training programs.
• Coordinate document control using the Veeva System.

Skills

Planning

Communication

Global collaboration

Problem solving

Presentation

Procedural documentation

Team motivation

MS Office

English fluency

Education

Bachelor’s degree in life sciences

Tools

Microsoft Office

Tracking databases

Job description

Remote Worker LTD. is seeking a Global Patient Safety Quality Management Manager to lead the PV QMS operations worldwide. You will oversee audit readiness, CAPA, training, and document control within GPS, collaborating with global teams.

The role emphasizes driving continuous improvement, KPI development, and successful regulatory interactions across regions, focusing on robust process execution in an office-based setting.