Vendor & Third-Party Management Quality And Compliance Manager - Spain - Fsp

Parexel FSP offers you the security of a long-term position and many opportunities for career progression. The Vendor & Third-Party Management Quality and Compliance Manager position 100% remotely gives you the opportunity to join a team with a wide range of experience and expertise. 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. 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. Ensure compliance with applicable SOPs, business guidance documents, quality standards, and regulatory requirements. Ensure the quality, accuracy, and completeness of due diligence and assessment documentation in TPM systems and tools. Process Improvement, Training and Stakeholder Collaboration Lead and/or contribute as a subject matter expert to the design, revision, implementation, and continuous improvement of GMA V&TPM quality, compliance, governance processes, standards, procedures, and guidance documents. Provide V&TPM quality and compliance expertise, guidance, and training to operational teams and stakeholders. Collaborate with ESP Quality Assurance, Medical QA, GMA Medical Governance & Risk Management, Procurement, Vendor & Partner Governance (VPG), and other relevant stakeholders to ensure effective oversight of third-party activities. Previous experience in Vendor & Third-Party Management, Quality Assurance, Compliance, or a similar role supporting clinical research or Medical Affairs activities. Clinical Trial/Medical Affairs experience in a pharmaceutical company or a Contract Research Organization (CRO) is required. Emphasis on business, experience with clinical/medical affairs processes and activities and associated external services, with excellent understanding of study management. Strong understanding of clinical and Medical Affairs processes, study management activities, and associated external services. Experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities. Strong understanding of Quality Management Systems, GCP/GVP requirements, audit processes, CAPA management, and risk management principles. Good understanding of clinical data systems/platforms and overall integration of clinical data system and processes Language proficiency: fluent written and spoken English knowledge Health, Dental & Vision. Excellent training. #