Experteer Overview As Manager, Quality Clinical Risk Management, you will lead risk identification, assessment, and proactive mitigation across clinical trials and programs.
You will translate risk signals into actionable plans, support inspection readiness, and guide cross-functional teams to ensure quality decisions.
You will drive risk monitoring, CAPA strategies, and governance reviews to protect patient safety and compliance.
This role combines hands-on risk ownership with influence across Ru**amp;D and quality partners, in a globally matrixed environment.
Compensaciones / Ventajas
• Identify and assess key risks in clinical protocol setup and trials; advise on mitigation strategies
• Lead regular risk reviews with Risk Owners to track mitigations and identify new risks
• Maintain Clinical Quality Plans (CQP) risk monitoring in quality risk repository
• Drive quality risk monitoring reviews and coach others on risk mitigation
• Communicate risk updates to Ru**D partners through Quality Working Groups and governance forums
• Develop and interpret issues requiring quality investigations and escalate Serious Quality Issues (SQI) as needed
• Provide CAPA guidance and support, including effectiveness checks
• Lead pre-submission Quality Portfolio Review (QPR) content and coordination
• Oversee inspection readiness activities,



develop narratives, prepare sites for inspection, and coordinate mock inspections
• Provide front and back room support for sponsor-monitor and third-party inspections
• Offer independent advice on research quality and regulatory compliance across boundaries
• Support quality integration of acquisitions/partners and contribute to quality agreements
• Participate in CRM and cross-functional groups to improve processes, tools, and systems
• Provide training and coaching to peers and new employees Responsabilidades
• 8+ years in healthcare/pharmaceutical industry or CRO experience
• GCP quality and/or clinical trials experience
• Cross-functional collaboration experience
• Proficiency in Microsoft Office
• Excellent English communication skills
• Capability to adapt to changing business needs and diverse regional contexts
• Knowledge of GMP, GLP, GPvP and ICH guidelines (preferred)
• Experience with data analytics or visualization tools (preferred)
• Experience with CAPA, issue escalation, and regulatory inspections (preferred) Requisitos principales
• annual bonus
• vacation days
• parential leave (12 weeks)
• bereavement leave
• well-being reimbursement
• insurance plans

📌 Manager, Quality Clinical Risk Management (Madrid)
🏢 Johnson u0026 Johnson
📍 Madrid