Vendor & Third-Party Management Quality and Compliance Manager - Spain - FSP

Hace 3 días

Vigo Pontevedra, Vigo (comarca); Provincia de Pontevedra; Galicia, España PAREXEL Jornada completa

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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

Vendor & Third-Party Management Quality and Compliance Manager - Spain - FSP

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Vendor &amp; Third-Party Management Quality and Compliance Manager - Spain - FSP

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Vendor & Third-Party Management Quality and Compliance Manager - Spain - FSP