Enrolled Nurse — Quality Care & Team Collaboration

Mediclinic; Cape Town; On-site; ZAR 2,592,000 - 3,517,000; Full time

Job summary

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

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

Responsibilities

• 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

Skills

Leadership

Project management

Data management

Regulatory knowledge

Stakeholder management

Communication

Problem-solving

Data analysis

Education

Bachelor's Degree or educational equivalence

Job description

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.

• 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.
• 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.
• Strong problem-solving, decision-making, and organizational abilities.
• Experience building and maintaining client and customer relationships at a senior level.
• Ability to work effectively in a matrix environment and deliver results through collaboration and influence.
• Demonstrated ownership, initiative, and a solutions-focused approach.
• Technical programming skills and experience producing Data Management deliverables.
• Ability to remain confident, diplomatic, and effective when managing challenging situations.
• High School Diploma or equivalent required.
• **No relocation opportunities provided**

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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