Overview

In this remote role, you provide Quality Assurance support for Integral 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 - españa
🏢 Parexel
📍 España