OverviewIn this role you will support Global Medical Affairs Vendor & Third-Party Management by driving quality events, investigations, deviations and CAPAs, and assisting with audits.
You will contribute to quality risk management, third-party oversight, and due diligence for RCs and non-vendor partners, sustaining compliance and continuous process improvement.
You'll collaborate with cross-functional teams to ensure inspection-ready records, evidence, and TPM tooling, shaping a robust quality framework for complex external collaborations.
This position offers a meaningful impact on patient outcomes by upholding high-quality external partnerships.
ResponsabilitàManage Quality Events, Quality Issues, deviations and related investigations with stakeholders
Act as Deviation Owner and support CAPA lifecycle from definition to closure
Support internal and external audits and audit readiness and remediation of findings
Ensure quality records and evidence are complete, traceable, and inspection ready
Support third-party governance and QRAs across GMA activities (NIS, RWE/RWD, RCs)
Identify, assess and escalate third-party risks from due diligence and oversight activities
Coordinate RC/non-vendor due diligence and ensure documentation accuracy in TPM systems
Maintain and improve TPM due diligence tools (e.g., TPIAT)
Lead/contribute to design,
revision and improvement of GMA V&TPM; governance processes
Provide quality/compliance training to operational teams and stakeholders
Collaborate with ESP QA, Medical QA, GMA Governance & Risk Management, Procurement, VPG and others for effective oversight
Requisiti fondamentaliDegree in life science or healthcare-related discipline
Experience in Vendor & Third-Party Management, QA, Compliance, or related roles in clinical research/Medical Affairs
Clinical Trial/Medical Affairs experience in pharma or CRO
Experience with external suppliers, research partners and cross-functional stakeholders
Strong understanding of clinical/Medical Affairs processes and external services
Knowledge of regulatory requirements in Clinical Research and drug development (GxP, ICH, FDA, EMA)
Understanding of Quality Management Systems, GCP/GVP, audit processes, CAPA and risk management
Knowledge of procurement processes and clinical data systems
Fluent written and spoken English
Strong problem-solving, negotiation and conflict resolution skills
Detail-oriented, accountable, multi-tasking, service-oriented
Experience in supervising third parties/external suppliers
problem-solving
negotiation
conflict resolution
GxP
Quality Management System
CAPA
📌 Vendor & Third-Party Management Quality & Compliance Manager (Latina)
🏢 Iqvia
📍 Latina