Manager, Serious Breach

Johnson & Johnson

Johnson & Johnson healthcare quality manager overseeing serious breach reporting for clinical trials. Coordinating regulatory assessments, metrics, dashboards, and process improvements across global stakeholders.

Posted 8/14/2026full-timeBeerse • 🇧🇪 BelgiumJunior💰 €79,800 - €137,770 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in serious breach reporting and detection processes, with a strong focus on clinical trial execution, risk management, and data-driven decision making. Proficient in developing oversight strategies, monitoring capabilities, and process improvements in collaboration with cross-functional teams.

Highest-signal resume keywords

Serious Breach ReportingClinical Trial ExecutionProject ManagementData Visualization ToolsGCP Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Document ManagementRisk Management FundamentalsData AnalysisProcess OptimizationQuality Performance Metrics

Soft Skills

Organizational SkillsMeeting FacilitationInterpersonal CommunicationAttention to DetailInfluencing Cross-Functional Teams

Tools & Technologies

TableauSpotfireMicrosoft Office Applications

Industry Keywords

PharmaceuticalMedical DeviceBiologicsHealth AuthorityICH Guidelines

Tech Stack

Tools & technologies

Google Cloud PlatformTableau

About the role

Key responsibilities & impact

Drive assessments and reporting of serious breach issues or events related to JJIM clinical trials to the appropriate Health Authorities
Serve as a primary subject matter expert for serious breach reporting and detection processes
Define, drive, and enhance oversight strategies and monitoring capabilities for the serious breach process
Facilitate early consultation and timely assessment of potential serious breaches across stakeholder organizations and JJIM leadership
Develop, assess, and report quality, efficiency, and risk performance metrics for serious breach process execution
Monitor process controls, effectiveness, and risk management requirements to develop optimization proposals
Deliver process improvements in collaboration with CRM and business partners including RDQA, GD, Legal, JJIMQ, and GRA
Create and monitor digital dashboards to support data-driven decision making
Represent the Serious Breach Office in process, strategic, and data review meetings
Develop templates, scorecards, and dashboards with RDQ and R&D stakeholders
Represent CRM-OpEx in core RDQ and business partner initiatives
Conduct regulatory research, competitor process benchmarking, external reporting analysis, and serious breach training activities
Manage projects independently and implement solutions addressing process gaps and improvement opportunities
Engage internal and external business partners, including Health Authorities, and summarize and present results

Requirements

What you’ll need

Bachelor's degree in a scientific, medical, or related discipline required
Minimum of 1–3 years of relevant health care industry experience required
Pharmaceutical, medical device, biologics company, and/or Health Authority experience required
Experience with clinical trial execution, clinical trial document management, and/or GCP compliance preferred
Strong organizational and project management skills required
Strong meeting facilitation skills required
Experience leading and influencing complex, cross-functional teams required
Experience with clinical trial risk management fundamentals, serious breach reporting requirements, and corresponding ICH guidelines required
Proficiency with Tableau, Spotfire, or related data visualization tools preferred
Ability to collect, analyze, interpret, and present data for data-driven decision making required
High degree of accuracy and attention to detail required
Excellent interpersonal, oral, and written communication skills required
Proficient in Microsoft Office Applications required
Ability to travel approximately 10%–15%, primarily domestically and/or internationally, required

Benefits

Comp & perks

Annual bonus with set target (% of pay) depending on pay grade / location
Vacation days
Parental leave for a minimum of 12 weeks
Bereavement leave
Caregiver leave
Volunteer leave
Well-being reimbursement
Programs for financial, physical and mental health
Service anniversary and recognition awards
Insurance plans for employees and, in some locations, eligible dependents