Manager, Quality Clinical Risk Management

Johnson & Johnson

. Participate in study activities, identify and assess clinical protocol/set-up risks, and advise on mitigation strategies .

Posted 10/23/2026full-timeUnited StatesSeniorLead💰 $102,000 - $177,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Clinical Quality Management, including risk assessment, mitigation strategies, and compliance with GCP and ICH guidelines. Proven ability to lead cross-functional teams, conduct quality investigations, and provide guidance on significant quality issues.

Highest-signal resume keywords

Clinical Quality ManagementRisk Assessment and MitigationGCP Quality ExperienceCross-Functional Team CollaborationHealth Authority Inspection Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Risk ManagementQuality ManagementQuality AssuranceData AnalyticsData VisualizationCAPA SupportProject PlanningDocument ManagementQuality Process DevelopmentInspection Readiness

Soft Skills

Interpersonal CommunicationCoaching and MentoringFlexibilityDecision-MakingCultural Sensitivity

Tools & Technologies

Microsoft Office ApplicationsTableauSpotfire

Industry Keywords

Healthcare IndustryPharmaceutical IndustryContract Research OrganizationGMPGLPGPvPICH GuidelinesFDAEMAReal World Evidence

Tech Stack

Tools & technologies

Google Cloud PlatformTableau

About the role

Key responsibilities & impact

Participate in study activities, identify and assess clinical protocol/set-up risks, and advise on mitigation strategies
Lead reviews of risk areas with Risk Owners and identify new risks or mitigation needs
Maintain Clinical Quality Plan risk-monitoring information in the quality risk repository
Drive quality risk-monitoring reviews and coach others on risk monitoring and mitigation
Communicate risk updates through Quality Working Groups and Governance Fora
Escalate potential systemic risks to Clinical Risk Management leadership
Develop consistent interpretations of issues requiring quality investigations
Provide guidance on significant quality issues and escalate them to senior R&D management
Conduct initial serious-breach evaluations and advise on Health Authority reporting
Advise on Corrective and Preventative Action Plans and Effectiveness Checks
Lead cross-functional Trial Teams and contributors in pre-submission Quality Portfolio Review content development and follow-up
Coach and mentor team members on Quality Portfolio Review activities
Drive inspection-readiness activities, inspection narratives, site preparation, document availability, and mock inspections
Provide front-room, back-room, post-inspection, remote, and third-party inspection support
Supervise and coach others on inspection readiness and support
Provide independent advice on research quality and compliance questions
Support quality integration for acquisitions, partnerships, and divestments
Provide input into Quality Agreements and execute assigned responsibilities
Participate in working groups to develop or refine quality processes, tools, and systems
Independently make decisions for compounds and studies
Train and coach peers and new employees

Requirements

What you’ll need

BA/BSc or equivalent in a scientific, medical, or related discipline
Minimum 8 years of experience working in the healthcare industry, pharmaceutical industry, contract research organization, and/or healthcare/hospital system
Proficiency in Microsoft Office Applications
Proficiency in speaking and writing English
Excellent interpersonal, oral, and written communication skills
Proven strong GCP quality and/or clinical trials experience
Experience collaborating in a cross-functional team environment
Flexibility to respond to changing business needs
Ability to operate in culturally diverse and global business environments
Up to 10% travel, primarily domestic with some international travel
Preferred: healthcare industry experience
Preferred: knowledge of GMP, GLP, and/or GPvP
Preferred: fundamentals of clinical trial risk management
Preferred: global clinical trial experience
Preferred: experience in Quality Management, Quality Assurance/Control, and/or Compliance
Preferred: experience with ICH guidelines
Preferred: Health Authority Inspection experience, including FDA and EMA
Preferred: strong project planning/management skills
Preferred: data analytics and/or data visualization tools such as Tableau or Spotfire
Preferred: ability to analyze and interpret collective data to drive decision-making
Preferred: experience managing escalations and CAPA support/advisement
Preferred: experience with Data Science and Digital Health, including Real World Evidence/Real World Disease

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents)
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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year