Quality Incident Lead – Data Management & CAPA

Digioutsource; Cape Town; In loco; ZAR 1.200.000 - 1.600.000; Tempo pieno

Descrizione del lavoro

IQVIA seeks an Assoc Director, Quality Lead in Data Management to drive quality management across the FSP. You will own quality incidents, guide investigations, and lead CAPA development, partnering with functional leads and SMEs to ensure root cause is identified and actions are tracked.

You will review TMF compliance, monitor QA metrics, and liaise with sponsors to communicate resolutions. A strong background in data management and clinical drug development is essential.

Competenze

• Advanced knowledge of Data Management processes, systems, and clinical drug development.
• Strong leadership, staff management, and team development skills.
• Proven project management experience with the ability to manage multiple priorities.
• Solid financial management, budgeting, and business acumen.
• Excellent communication, presentation, negotiation, and stakeholder management skills.

Mansioni

• Act as the primary issue owner and centralized manager for any quality incidents (QI) logged in IQVIA Quality Management System or Customer Quality System across the CDM FSP.
• Coordinate targeted investigation for QIs; include resource requests of Functional Leads to support investigations.
• Direct functional leads/SMEs in investigations, using root-cause methods to ensure correct CAPAs and documentation.
• Escalate to Leadership Team when cross-functional support is needed to establish root cause and CAPA timely.
• Conduct and track portfolio-level investigations, summarizing outputs in QMS and drive CAPA implementation.

Conoscenze

Advanced data management

Leadership

Project management

Budgeting

Communication

Problem solving

Stakeholder management

Matrix teamwork

Technical programming

Industry knowledge

Formazione

Bachelor's degree or equivalent

Descrizione del lavoro

IQVIA seeks an Assoc Director, Quality Lead in Data Management to drive quality management across the FSP. You will own quality incidents, guide investigations, and lead CAPA development, partnering with functional leads and SMEs to ensure root cause is identified and actions are tracked.

You will review TMF compliance, monitor QA metrics, and liaise with sponsors to communicate resolutions. A strong background in data management and clinical drug development is essential.