Assoc Director, Quality Lead, Data Management FSP

Overview

Join IQVIA, a global leader in clinical research, to drive quality across data management. In this role you own quality incidents and guide investigations across the Quality Management System, coordinating SMEs to identify root causes and implement CAPAs. You monitor data, report progress to sponsors, and ensure regulatory readiness through portfolio-level quality management. You’ll work with cross‑functional teams to improve data quality and maintain client relationships in a matrix environment.

Responsibilities

• Act as primary issue owner for quality incidents across QMS and Customer QMS
• Coordinate targeted investigations and request resources from Functional Leads
• Direct SMEs in investigations using root-cause methodologies (e.g., 5 whys) and document QI/CAPA outcomes
• Escalate to Leadership when necessary to obtain timely root cause and CAPA
• Conduct and track portfolio-level investigations and drive CAPA implementation with support
• Review aggregated QI data, analyze trends, and communicate recurring findings to internal teams and Sponsor
• Provide CAPA progress updates to customers and discuss corrective actions
• Negotiate with customers to align on root cause and ownership, escalating when needed
• Monitor TMF compliance and support audit/inspection readiness across the portfolio
• May conduct internal Data Management Quality Reviews and monitor portfolio KPIs
• Provide leadership and innovative quality insights to the portfolio
• Serve as Subject Matter Expert on quality incidents and process improvement for CDM management
• Maintain knowledge of applicable regulatory and Sponsor guidelines and review techniques

Key requirements

• Advanced knowledge of Data Management processes, systems, and clinical drug development
• Strong leadership, staff management, and team development skills
• Proven project management experience with ability to manage multiple priorities
• Solid financial management, budgeting, and business acumen
• Excellent communication, presentation, negotiation, and stakeholder management skills
• Strong problem-solving, decision-making, and organizational abilities
• Experience building and maintaining client relationships at a senior level
• Ability to work effectively in a matrix environment and deliver results through collaboration and influence
• Demonstrated ownership, initiative, and a solutions-focused approach
• Technical programming skills and experience producing Data Management deliverables
• Ability to remain confident, diplomatic, and effective in challenging situations
• High School Diploma or equivalent

• leadership
• stakeholder management
• communication
• Data Management processes
• quality incident management
• CAPA

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