Serious Breach Office Manager: Clinical Risk Leader

Johnson & Johnson Innovation; New Jersey; On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Vacation 120 hours/yr

Sick time 40–56 hours/yr

Floating holidays 13 days/yr

Parental Leave 480 hours/yr

Bereavement Leave 240 hours/yr

Volunteer Leave 32 hours/yr

Military Spouse Time-Off 80 hours/yr

Job summary

Johnson & Johnson is seeking a Manager for the Serious Breach Office (SBO). The role supports Clinical Risk Management-Operational Excellence across NA/EMEA, with a preference for NJ-based locations such as Raritan, New Brunswick, or Titusville.

The SBO Manager will facilitate breach reporting, coordinate with RDQ partners, and drive continual process improvement to ensure timely, compliant reporting to Health Authorities.

Qualifications

• Minimum 1-3 years of relevant experience in the health care industry.
• Experience in clinical trial risk management, reporting, and GCP compliance preferred.
• Strong organizational and project management skills are required.

Responsibilities

• Serious Breach Office (SBO) lead: drive assessments and reporting of events meeting serious breach criteria to Health Authorities.
• SBO Lead: define oversight strategies and monitoring for serious breach process within clinical trial risk framework.
• Process Performance Monitoring: develop, assess, and report metrics on quality, efficiency, and risk of breach reporting.
• Continual Improvement Driver: propose optimized controls and process improvements with cross-functional partners.
• Data Analysis and Visualization: create dashboards to enable data-driven decisions on breach reporting.
• Leadership in Serious Breach Meetings: represent SBO in reviews with executive presence and actionable outcomes.
• Collaboration with stakeholders: work with RDQ and partners to develop templates, scorecards, and dashboards.

Skills

Cross-functional leadership

Project management

Data visualization

Microsoft Office

Healthcare industry experience

Clinical trial experience

Education

Bachelor's degree in science/medical field

Tools

Tableau

Spotfire

Microsoft Office

Job description

Johnson & Johnson is seeking a Manager for the Serious Breach Office (SBO). The role supports Clinical Risk Management-Operational Excellence across NA/EMEA, with a preference for NJ-based locations such as Raritan, New Brunswick, or Titusville.

The SBO Manager will facilitate breach reporting, coordinate with RDQ partners, and drive continual process improvement to ensure timely, compliant reporting to Health Authorities.