Paint Shop Lead: Quality, Safety & Efficiency

Pump And Abrasion Technologies; South Africa; Presencial; ZAR 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

IQVIA is seeking an Assoc Director, Quality Lead in Data Management FSP to lead quality management across a portfolio of customer data projects. The role focuses on incident ownership, CAPA execution, and TMF compliance to ensure audit readiness.

You will coordinate investigations with functional leads, analyze trends, and provide updates to sponsors, while guiding a team of data management professionals toward continuous quality improvements and regulatory alignment.

Formación

• Bachelor's Degree Or educational equivalence in clinical, biological or mathematical sciences or related field; nursing qualification with 10 years of relevant work experience.

Responsabilidades

• Act as the primary issue owner for quality incidents logged in IQVIA systems.
• Coordinate investigations and request resources from Functional Leads.
• Direct SMEs in investigations using root-cause methods and document CAPA actions.

Conocimientos

Leadership

Data Management

Quality Incidents

CAPA

TMF Compliance

Educación

Bachelor's Degree or equivalent

Descripción del empleo

• What Paint Shop Lead Quality Safety Efficiency...

Assoc Director, Quality Lead, Data Management FSP

Dublin, Ireland
Centurion, South Africa
Reading, Berkshire, United Kingdom
Bloemfontein, South Africa
Bellville, South Africa
Full time
R

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) for quality to supplement functional leadership management and reporting of quality
• Provide leadership and innovative ideas to the portfolio from a quality incident perspective
• Serve as Subject Matter Expert, providing quality incident and process improvement expertise to CDM management
• Maintain working knowledge of current applicable regulatory and Sponsor guidelines and related review techniques

Qualifications

• Bachelor's Degree Or educational equivalence, in clinical, biological or mathematical sciences or related field, or nursing qualification with 10 years of relevant work experience including substantial people management experience; or equivalent combination of education, training and experience

Requirements

• Advanced knowledge of Data Management processes, systems, and clinical drug development.
• Strong leadership, staff management, and team development skills.