Serious Breach Office Manager — Clinical Quality

Denttach LLC; Raritan (NJ); Hybrid; USD 102,000 - 177,000; Full time

Benefits offered by this job

Pension plan

401(k) plan

Generous time off

Job summary

Johnson & Johnson is recruiting for a Manager, Serious Breach Office. Location preferences include Raritan, NJ, Horsham PA, or nearby NJ/PA sites. The role sits in Clinical Risk Management-Operational Excellence within RDQ and drives serious breach reporting for JJIM sponsored trials across NA/EMEA.

The SBO Manager coordinates with stakeholders to assess quality issues, implement reporting processes, and deliver data-driven improvements. Travel ~10-15% domestic/international.

Qualifications

• Bachelor's degree in scientific, medical or related discipline.
• 1-3 years of healthcare industry experience required.
• Experience with clinical trial risk management and ICH guidelines preferred.

Responsibilities

• Serve as SBO Lead to drive serious breach assessments and reporting to Health Authorities.
• Define and enhance oversight strategies for serious breach process within clinical trial risk management.
• Develop and report performance metrics for process quality, efficiency and risk.
• Lead cross-functional collaboration with RDQ, GD, Legal and other partners to drive improvement.
• Create dashboards to monitor process effectiveness and enable data-driven decisions.

Skills

Organizational skills

Project management

Cross-functional collaboration

Communication

Regulatory understanding

Data interpretation

Education

Bachelor's degree in scientific/medical field

Tools

Tableau

Spotfire

Job description

Johnson & Johnson is recruiting for a Manager, Serious Breach Office. Location preferences include Raritan, NJ, Horsham PA, or nearby NJ/PA sites. The role sits in Clinical Risk Management-Operational Excellence within RDQ and drives serious breach reporting for JJIM sponsored trials across NA/EMEA.

The SBO Manager coordinates with stakeholders to assess quality issues, implement reporting processes, and deliver data-driven improvements. Travel ~10-15% domestic/international.