16 set - Varese
Iqvia
Job Overview
The position provides Quality Assurance support for Global Medical Affairs Vendor & Third-Party Management, primarily through the management of quality events, quality issues, deviations, and Corrective and Preventive Actions (CAPAs), as well as audit support and audit readiness. The role also supports Research Collaboration (RC) due diligence and selected non-vendor third-party assessment activities and contributes to third-party quality risk management, compliance, and continuous process improvement.
Quality Events, CAPAs and Audit Readiness
- Manage Quality Events (QEs), Quality Issues (QIs), deviations, and related investigations in collaboration with relevant stakeholders.
- Act as Deviation Owner, as appropriate, and support CAPA definition, implementation, tracking, effectiveness assessment, and closure.
- Support internal and external audits, audit readiness activities, and the remediation of audit findings.
- Ensure quality records, supporting documentation, and evidence are complete, accurate, traceable, and inspection ready.
V&TPM; Quality Risk Management and Compliance
- Support third-party governance and oversight activities from a quality and compliance perspective.
- Support and contribute to third-party Quality Risk Assessments (QRAs) and ensure assessments are completed, documented, and maintained for relevant GMA activities, including non-interventional studies (NIS), real-world evidence and real-world data (RWE/RWD) activities, Research Collaborations (RCs), and partnerships. Follow up on identified risks and associated mitigation actions, as appropriate.
- Identify, assess, and escalate potential risks arising from third-party due diligence, qualification, and oversight activities.
- Ensure compliance with applicable SOPs, business guidance documents, quality standards, and regulatory requirements.
Research Collaboration/non-vendor Due Diligence and Assessment
- Support Research Collaboration (RC) and other selected third-party (non
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