Quality Lead - Data Management & CAPA Excellence

Mediclinic; Cape Town; In loco; ZAR 2.592.000 - 3.517.000; Tempo pieno

Descrizione del lavoro

IQVIA in multiple global locations seeks an Assoc Director, Quality Lead, Data Management FSP to lead quality management across a customer data management function. The role focuses on incident ownership, CAPAs, and portfolio-level QA activities, ensuring audit readiness and regulatory adherence.

The successful candidate will guide functional leads, use root-cause methods, and drive CAPA implementation while maintaining strong stakeholder relationships and strategic oversight across a matrix

Competenze

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

Mansioni

• 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

Conoscenze

Leadership

Project management

Data management

Regulatory knowledge

Stakeholder management

Communication

Problem-solving

Data analysis

Formazione

Bachelor's Degree or educational equivalence

Descrizione del lavoro

IQVIA in multiple global locations seeks an Assoc Director, Quality Lead, Data Management FSP to lead quality management across a customer data management function. The role focuses on incident ownership, CAPAs, and portfolio-level QA activities, ensuring audit readiness and regulatory adherence.

The successful candidate will guide functional leads, use root-cause methods, and drive CAPA implementation while maintaining strong stakeholder relationships and strategic oversight across a matrix