Experteer Overview In this role you will lead clinical quality risk management within the Ru0026amp; D Quality CRM team to translate risk signals into proactive mitigations and ensure inspection readiness. You will work across trials and programs, partnering with cross-functional teams to drive quality decisions and CAPA actions. The position combines hands-on risk ownership with broad influence to safeguard patient safety and regulatory compliance. This opportunity lets you shape risk management processes in a integral, innovative healthcare environment.
Compensaciones / Beneficios
- Identify and assess key risks in clinical protocols and trial setup and advise on mitigation strategies
- Lead periodic reviews of risk areas with Risk Owners and monitor progress of mitigations
- Maintain risk monitoring data in the quality risk repository for ongoing progress reviews
- Coach team members on risk monitoring, mitigation reviews, and quality risk practices
- Communicate risk updates to Ru0026D Business Partners via Quality Working Groups and Governance Fora
- Develop guidance on quality investigations and escalate significant quality issues (SQIs) to senior management
- Provide CAPA guidance and lead pre-submission quality portfolio reviews (QPR) including content development




- Drive inspection readiness activities, prepare inspection narratives, and coordinate mock inspections and site readiness
- Support and supervise sponsor-monitor inspections and remote site inspections as needed
- Contribute to cross-functional CRM and process improvement initiatives and provide training to peers and new hires
- Support integration activities for asset acquisitions/divestitures and participate in quality agreementsResponsabilidades
- BA/BSc or equivalent in scientific, medical, or related discipline
- minimum 8 years of related experience in healthcare/pharmaceutical/clinical quality
- proficiency in Microsoft Office Applications
- proficiency in speaking and writing English
- excellent interpersonal, oral, and written communication skills
- strong GCP quality and/or clinical trials experience
- experience collaborating in cross-functional teams
- flexibility to respond to changing business needs
- ability to operate in diverse, global business environments
- up to 10% travel, domestically and internationallyRequisitos principales
- annual bonus
- vacation days
- parental leave
- bereavement leave
- well-being reimbursement
- insurance plans

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