Quality Assurance: Consultant

Sars; Pretoria; On-site; ZAR 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Hybrid work arrangement

Pension fund contribution

Health and wellness benefits

Paid time off

Professional development and training

Company-provided equipment for remote

Salary and performance incentives

Job summary

IQVIA is seeking an Assoc Director, Quality Lead for Data Management FSP to lead quality management in a team delivering databases that meet customer requirements. The role requires strong leadership, regulatory knowledge, and data management expertise across multiple global sites.

Responsibilities include managing QI incidents, guiding CAPA programs, coordinating with functional leads, and ensuring TMF and KPI oversight. Hybrid work model with Centurion, SA as a key location.

Qualifications

• Bachelor's degree or educational equivalence in clinical, biological or mathematical sciences or related field.
• Advanced knowledge of Data Management processes and clinical drug development.
• Strong leadership and people management experience.

Responsibilities

• Develop and maintain a QMS in line with ISO 9001.
• Lead and mentor the Quality Assurance team.
• Oversee QC activities including inspections and testing.
• Conduct root cause analysis and implement CAPAs.
• Collaborate with production, engineering and R&D.
• Manage internal and external audits and certifications.
• Track KPIs and report to senior management.
• Drive continuous quality improvement.
• Ensure regulatory compliance and customer specs.

Skills

Leadership

Project management

Quality management

Regulatory knowledge

Data management

Stakeholder management

Analytical thinking

Education

Bachelor's Degree in clinical/scientific field

Nursing qualification with 10 years' experience

Tools

Quality Management System (QMS)

CAPA tracking tools

ISO 9001 knowledge

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.
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.
• 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.EEO Minorities/Females/Protected Veterans/Disabled

Our client, a prominent player in the specialized manufacturing sector, is actively seeking a seasoned Quality Assurance Manager to oversee and enhance their product quality systems. This role requires a strategic leader who can implement robust QA protocols, ensure compliance with industry standards, and drive a culture of quality throughout the organization. While the role is primarily based in our Centurion, Gauteng facility, a hybrid work model is in place, allowing for a balance between on-site collaboration and remote flexibility. You will be responsible for developing and executing quality control strategies, managing the QA team, and acting as the primary liaison for all quality-related audits and inspections. This is a critical position for maintaining our client's reputation for excellence and delivering superior products to their customers.

About the Role

Our client, a prominent player in the specialized manufacturing sector, is actively seeking a seasoned Quality Assurance Manager to oversee and enhance their product quality systems. This role requires a strategic leader who can implement robust QA protocols, ensure compliance with industry standards, and drive a culture of quality throughout the organization. While the role is primarily based in our Centurion, Gauteng facility, a hybrid work model is in place, allowing for a balance between on-site collaboration and remote flexibility. You will be responsible for developing and executing quality control strategies, managing the QA team, and acting as the primary liaison for all quality-related audits and inspections. This is a critical position for maintaining our client's reputation for excellence and delivering superior products to their customers.

Key Responsibilities

• Develop, implement, and maintain a comprehensive quality management system (QMS) in accordance with relevant industry standards (e.g., ISO 9001).
• Lead and mentor the Quality Assurance team, including QA inspectors and technicians.
• Oversee all quality control activities, including product inspections, testing, and process monitoring.
• Conduct root cause analysis for quality deviations and implement corrective and preventive actions (CAPA).
• Collaborate with production, engineering, and R&D departments to ensure quality is integrated into all stages of product development and manufacturing.
• Manage internal and external audits, inspections, and certifications.
• Develop and track key quality metrics and KPIs, reporting on performance to senior management.
• Ensure compliance with all regulatory requirements and customer specifications.
• Drive continuous improvement initiatives within the QA department and across the manufacturing operations.
• Maintain detailed records of quality control activities and product testing results.

Requirements

• Bachelor's degree in Engineering, Science, or a related technical field.
• Minimum of 5 years of experience in Quality Assurance or Quality Control within a manufacturing environment.
• Proven experience in implementing and managing QMS, preferably with ISO 9001 certification.
• Strong understanding of quality control methodologies, statistical process control (SPC), and root cause analysis techniques.
• Excellent leadership, team management, and communication skills.
• Experience with audit processes and regulatory compliance.
• Proficiency in quality management software and data analysis tools.
• Ability to work effectively in both an on-site and remote capacity as per the hybrid model.
• Detail-oriented with a strong commitment to accuracy and precision.
• Problem-solving skills and a proactive approach to quality improvement.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health and wellness benefits package.
• Hybrid work arrangement offering flexibility.
• Opportunities for professional development and training.
• Pension fund contribution.
• Paid time off.
• Exposure to diverse manufacturing processes and technologies.
• A collaborative and supportive work environment focused on quality excellence.
• Career advancement opportunities within a growing organization.
• Company-provided equipment for remote work.