Manager, Serious Breach

Johnson & Johnson

Johnson & Johnson clinical quality manager overseeing serious breach reporting for sponsored clinical trials. Driving risk assessments, regulatory compliance, process improvement, and data-informed decisions across global stakeholders.

Posted 8/14/2026full-timeRaritan • New Jersey, Pennsylvania • 🇺🇸 United StatesJunior💰 $102,000 - $177,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in serious breach reporting and clinical trial risk management, with a strong focus on data analysis, project management, and stakeholder communication. Proficient in developing performance metrics and utilizing data visualization tools to enhance decision-making processes.

Highest-signal resume keywords

Serious Breach ReportingClinical Trial Risk ManagementData Visualization ToolsProject ManagementGCP Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ExecutionData AnalysisPerformance Metrics DevelopmentRegulatory Landscape ResearchSerious Breach TrainingDocument ManagementRisk Management FundamentalsMeeting FacilitationInterpreting DataAttention to Detail

Soft Skills

Organizational SkillsInterpersonal CommunicationWritten CommunicationLeadershipInfluencing Teams

Tools & Technologies

TableauSpotfireMicrosoft Office

Industry Keywords

PharmaceuticalMedical DeviceBiologicsHealth AuthorityICH Guidelines

Tech Stack

Tools & technologies

Google Cloud PlatformTableau

About the role

Key responsibilities & impact

Facilitate serious breach assessments and reporting for JJIM-sponsored clinical trials to 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 within the clinical trial risk and issue management framework
Facilitate early consultation and timely assessment across stakeholder organizations and JJIM leadership
Develop, assess, and report performance metrics for quality, efficiency, risk, and timely case reporting
Monitor process controls, effectiveness, and risk management requirements to identify optimization opportunities
Deliver improvements to the serious breach process with CRM and business partners including RDQA, GD, Legal, JJIMQ, and GRA
Create and monitor digital dashboards to support interpretation and 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 landscape research, competitor benchmarking, external reporting analysis, and serious breach training activities
Manage projects independently and present results to internal, external, and Health Authority stakeholders

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 in 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 data visualization tools such as Tableau or Spotfire preferred
Ability to collect, analyze, interpret, and present data required
High degree of accuracy and attention to detail required
Excellent interpersonal, oral, and written communication skills required
Proficiency in Microsoft Office applications required
Ability to travel approximately 10%–15%, primarily domestically and/or internationally, required

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview process and accommodation support for applicants with disabilities