Senior Manager, It Compliance
2 weeks ago
About the RoleIQVIA is seeking a strategic and experiencedSenior Manager, IT Compliance & Validationto serve as a key liaison between our sponsors, internal IT product teams, and enterprise quality assurance.This high-impact role ensures that our technology solutions meet global regulatory requirements and align with sponsor expectations across the product lifecycle.You will lead sponsor-facing compliance initiatives, advise on GxP-regulated system design and validation, and play a critical role in fulfilling IQVIA's compliance commitments in a dynamic, regulated environment.Key ResponsibilitiesSponsor Engagement & Relationship ManagementAct as the primary IT Compliance & Validation lead for assigned sponsors or clients.Define and execute sponsor oversight and engagement strategies to meet compliance commitments.Represent IQVIA's Quality Management in sponsor meetings, audits, and inspections.Serve as the escalation point for sponsor-reported IT compliance and quality issues.IT Compliance & Validation LeadershipGuide product teams on regulatory requirements and validation strategies for GxP-regulated systems.Lead system compliance assessments, risk evaluations, and validation planning.Ensure alignment with IQVIA's Quality Management System and global regulatory standards.Regulatory Strategy & Risk ManagementInterpret and apply global regulations (e.g., FDA, EMA, MHRA, 21 CFR Part 11, GxP) to IT systems and processes.Develop validation methodologies and communication strategies for sponsor-facing projects.Partner with QA to ensure vendor compliance and recommend actions to align with sponsor expectations.Cross-Functional CollaborationCollaborate with IT, QA, and product teams to ensure validation deliverables are accurate, complete, and audit-ready.Drive alignment of system lifecycle and validation processes across internal teams.Support the development of compliance KPIs to track partnership effectiveness.Qualifications & ExperienceMust-Have:Bachelor's degree in Computer Science, Life Sciences, Information Systems, or related field (Master's preferred).Substantial experience in IT compliance, validation, or quality roles within life sciences, pharma, or CROs.Strong knowledge of GxP, 21 CFR Part 11, and global regulatory frameworks.Proven experience leading sponsor/client engagements and managing audits or inspections.Excellent communication, stakeholder management, and documentation skills.Nice-to-Have:Experience with cloud-based systems and modern validation approaches (e.g., CSA).Familiarity with audit trail review tools or automated validation platforms.Knowledge of Privacy by Design principles and software quality assurance best practices.Why Join Us?At IQVIA, you'll be part of a global leader in healthcare data science and technology.You'll work with top-tier clients, cutting-edge systems, and a team that values innovation, compliance, and collaboration.Ready to Apply?If you're passionate about driving compliance excellence in a sponsor-facing role and thrive in a regulated, fast-paced environment, we'd love to hear from you.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#J-*****-Ljbffr
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