Senior Quality Lead – Data Management & Packaging

Kheper Sa Pty Ltd T/A Silki; Cape Town; In loco; ZAR 1.666.000 - 2.407.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Assoc Director, Quality Lead, Data Management FSP to oversee quality management within a scope spanning multiple regions. The role emphasizes incident ownership, root cause analysis, CAPA development, and portfolio-level quality improvements.

The candidate will coordinate investigations with functional leads, ensure TMF and data management compliance, and drive quality readiness for audits. Strong communication with Sponsors and customers is essential.

Competenze

• Lead Quality Management processes across the Data Management FSP to meet customer requirements.
• Coordinate investigations of quality incidents using root cause methods (e.g., 5 whys) and document CAPA actions.
• Escalate to Leadership when root cause or CAPA support is unavailable.
• Monitor TMF compliance and participate in internal quality reviews as required.

Mansioni

• Act as primary owner for quality incidents across the Customer Data Management FSP.
• Direct functional leads/ SMEs in investigations and CAPA execution.
• Review data for trends; communicate findings to Sponsor and teams.
• Provide updates on CAPA progress and negotiate with customers when needed.

Conoscenze

Quality incident management

CAPA handling

Root cause analysis

Quality management systems

Data management

TMF/eTMF review

Strumenti

IQVIA Quality Management System

TMF Review tools

Descrizione del lavoro

IQVIA is seeking a Assoc Director, Quality Lead, Data Management FSP to oversee quality management within a scope spanning multiple regions. The role emphasizes incident ownership, root cause analysis, CAPA development, and portfolio-level quality improvements.

The candidate will coordinate investigations with functional leads, ensure TMF and data management compliance, and drive quality readiness for audits. Strong communication with Sponsors and customers is essential.