05 oct
|
Parexel
|
Sevilla
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 / Incentivos * 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 (Sevilla)
🏢 Parexel
📍 Sevilla