Quality Lead, Computer System Validation & Regulatory Compliance

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, Technology, analytics and human ingenuity to drive healthcare forward.

We are seeking an experienced Quality Lead to provide quality assurance leadership and

regulatory compliance oversight for business-critical technology solutions. This role serves as

the primary liaison between Quality Management and project teams, ensuring that computer

systems are developed, validated, and maintained in accordance with applicable regulatory

requirements and internal quality standards.

The successful candidate will play a key role in guiding teams through the Software

Development Life Cycle (SDLC), ensuring compliance with regulations and industry best

practices for computerized systems validation (CSV). This position combines quality leadership,

risk management, process improvement, and hands-on collaboration with product,

engineering, testing, and business teams.

Regulatory Compliance & Quality Oversight

• Provide expert guidance on quality assurance and regulatory compliance requirements

throughout the system development lifecycle.

• Ensure computerized systems are validated and maintained in compliance with

applicable regulations, industry standards, and IQVIA quality processes.

• Review and approve SDLC deliverables, validation documentation, and quality records.

• Support project teams in interpreting and applying regulatory requirements to

technology solutions and business processes.

• Identify compliance gaps, deviations, and quality risks, ensuring appropriate escalation

and resolution.

Computer System Validation (CSV)

• Lead quality oversight activities related to system validation, testing, releases, and data

migration efforts.

• Review validation documentation including requirements, risk assessments, test plans,

test cases, test evidence, and validation reports.

• Ensure releases are appropriately classified (Operational, Patch, Minor, or Major) in

accordance with SDLC guidelines.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and

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 https://jobs.iqvia.com

IQVIA 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.