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.
Key Responsibilities
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.
Please submit your CV in English.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. It creates intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
The potential base pay range for this role, when annualized, is €28,500.00 - €42,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
