Sr. QA Auditor

Responsibilities

• Plan, schedule, conduct, and close independent audits to assess compliance with regulations, customer requirements, and IQVIA SOPs
• Evaluate audit findings and prepare detailed reports for management, operations staff, and customers
• Provide consultation to project teams and customers regarding regulations, compliance status, and corrective action plans
• Manage quality issues by reviewing and approving investigations, Root Cause Analysis (RCA), and CAPA plans
• Support management in promoting compliance through educational programs and guidance to operational staff
• Host and support customer-initiated audits, mock regulatory inspections, and actual regulatory facility inspections
• Maintain the electronic quality management system (eQMS) and oversee quality event updates
• Lead or collaborate on QA initiatives and process improvement projects

Requirements

• Bachelor's Degree
• 5 years of experience in pharmaceutical, technical, or a related field
• 3 years of dedicated Quality Assurance experience
• Direct experience working within GXP environments
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments
• Strong knowledge of quality assurance processes and procedures
• Excellent problem-solving, risk analysis, and negotiation skills
• Ability to work independently and manage multiple projects simultaneously

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.