Production & Packaging Technician

Kheper Sa Pty Ltd T/A Silki; Cape Town; On-site; ZAR 1,666,000 - 2,407,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality incident management

CAPA handling

Root cause analysis

Quality management systems

Data management

TMF/eTMF review

Tools

IQVIA Quality Management System

TMF Review tools

Job description

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Assoc Director, Quality Lead, Data Management FSP

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**Quality Lead Job Overview**
Lead Quality Management processes in a team of Data Management professionals to efficiently produce databases that meet customer requirements.
**Quality Lead Functions**

• Act as the primary issue owner and centralized manager for any quality incidents (QI) logged in the IQVIA Quality Management System or Customer Quality System across the Customer Data Management Functional Service Partnership (FSP).
• Coordinate targeted investigation for QIs; includes making targeted resource requests of the relevant Functional Leads to support the QI investigations.
• Direct the appropriate functional lead member(s)/SMEs in the investigation, utilizing quality issue investigation principles e.g. 5 whys to ensure the team establish the correct root cause and effective CAPAs, bringing together all inputs and documenting the QI investigation summary and CAPA clearly.
• Escalating to Leadership Team where the required support is not available from within the functions to establish the correct root cause and/or CAPA in a timely manner.
• Conduct and track partnership level investigations, summarizing outputs in the Quality Management System and drive portfolio level CAPA implementation (with support from the Functional Lead from the relevant function).
• Review aggregated QI data and performs analysis and identification of trends at portfolio level and ensure that recurring findings/errors are communicated internally and to the Sponsor.
• Provides updates on CAPA progress to Customer and share corrective/preventative actions for review and discussion where appropriate.
• Negotiation with customer where different views exist on root cause and ownership of quality issues to ensure that IQVIA's position is explained clearly with rationale, escalating where appropriate.
• Monitor Trial Master File (TMF) compliance across the portfolio supporting audit/inspection readiness to supplement functional accountability.
• May conduct internal Data Management Quality Reviews, including eTMF Reviews, as part of the portfolio Quality Management Team in order to fulfil business unit, customer and regulatory authority requirements and expectations.
• May monitor portfolio level customer Key Performance Indicators (KPIs