Vendor & Third-Party Management Quality and Compliance Manager - Spain - FSP
hace 11 horas
Vigo
Overview In this remote role, you provide Quality Assurance support for Global Medical Affairs Vendor & Third-Party Management, handling quality events, investigations, CAPAs, audits, and due diligence. You collaborate with cross-functional partners to ensure compliance, risk management, and audit readiness across third-party activities. You will lead process improvements and training to sustain high standards in governance, quality, and regulatory compliance. This position offers remote work in Spain with a mission-driven, collaborative team enhancing patient outcomes. Compensaciones / Beneficios • Premium salary, • Attractive benefits, • Medical care plan: Health, Dental & Vision, • Life Assurance, • Excellent work environment, • Culture of teamwork and collaboration Responsabilidades • Manage Quality Events, Quality Issues, deviations, and investigations; act as Deviation Owner and support CAPA lifecycle, • Support internal and external audits and remediation of findings; ensure evidence traceability and inspection readiness, • Contribute to third-party governance, QRAs, and risk assessments for GMA activities including NIS and RWE/RWD, • Oversee RC and non-vendor due diligence activities; ensure documentation quality and TPM tool maintenance (TPIAT), • Design and implement improvements to GMA V&TPM quality, compliance, governance processes and guidance, • Provide QA expertise and training to operational teams; collaborate with cross-functional stakeholders for effective oversight Requisitos principales • Degree in a life science or healthcare-related discipline, • Experience in Vendor & Third-Party Management, Quality Assurance, Compliance or similar in clinical research/Medical Affairs, • Clinical Trial/Medical Affairs experience in pharma or CRO, • Experience with external suppliers and cross-functional stakeholders within pharma/CRO, • Strong understanding of clinical/Medical Affairs processes and study management, • Knowledge of regulatory requirements in Clinical Research and drug development (FDA, EMA, ICH) and GxP, QMS, CAPA, risk management, • Procurement understanding and knowledge of clinical external suppliers landscape (CROs, labs, eCOA, new tech), • Ability to manage/supervise third parties and external providers, • Good understanding of clinical data systems and integration of data processes, • Fluent written and spoken English, • Strong problem-solving, negotiation and conflict-resolution skills, • Diligent, detail-oriented, accurate, accountable, multi-tasking, service-oriented, • problem-solving, • negotiation, • conflict resolution, • GxP knowledge; CAPA and risk management, • Quality Management System understanding (GCP/GVP), • Audit processes and CAPA management