Global Clinical Quality Risk Manager

6014-Janssen Biotech, Inc. Legal Entity; Madrid; On-site; EUR 62,000 - 106,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson is seeking a Manager, Quality Clinical Risk Management to join the R&D Quality CRM team. The role focuses on translating risk signals into proactive mitigation, escalation, and quality decision support across trials and programs.

It combines hands-on risk ownership with substantial cross-functional influence across multiple sites and countries. Responsibilities include leading risk reviews, ensuring inspection readiness, and guiding CAPA activities while collaborating with RDQ

Qualifications

• Required knowledge: GMP/GLP/GPvP principles and ICH guidelines.
• Proficient in Microsoft Office applications and data analysis tools.
• Strong written and spoken English; excellent interpersonal communication.
• Experience in quality management, CAPA, risk assessment and inspection readiness.

Responsibilities

• Identify and assess key risks in clinical protocols and study setup; advise on mitigation.
• Lead regular risk reviews with risk owners to track mitigations.
• Develop and maintain quality risk monitoring information and dashboards.
• Provide guidance on serious quality issues and escalation to senior management.
• Coordinate CAPA planning and cross-functional trial team activities.

Skills

Office proficiency

English proficiency

Communication skills

Project management

Quality/regulatory awareness

Education

BA/BSc or equivalent

Tools

Tableau

Spotfire

Job description

Johnson & Johnson is seeking a Manager, Quality Clinical Risk Management to join the R&D Quality CRM team. The role focuses on translating risk signals into proactive mitigation, escalation, and quality decision support across trials and programs.

It combines hands-on risk ownership with substantial cross-functional influence across multiple sites and countries. Responsibilities include leading risk reviews, ensuring inspection readiness, and guiding CAPA activities while collaborating with RDQ