Manager, Quality Clinical Risk Management

Johnson & Johnson

. Identify and assess key risks in clinical protocols and study setup, and advise clinical teams 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 risk management, quality assurance, and compliance within the healthcare and pharmaceutical industries. Proficient in leading cross-functional teams, conducting quality investigations, and providing strategic guidance on risk mitigation and quality processes.

Highest-signal resume keywords

Clinical Risk ManagementGood Clinical Practice (GCP)Quality Assurance/ControlCross-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 ManagementData AnalyticsData VisualizationProject PlanningCorrective and Preventative Action Plans (CAPA)Quality Portfolio Review CoordinationQuality IntegrationQuality Risk MonitoringQuality InvestigationsInspection Readiness

Soft Skills

Interpersonal CommunicationCoaching and MentoringFlexibilityDecision-MakingCultural Adaptability

Tools & Technologies

Microsoft Office ApplicationsTableauSpotfire

Industry Keywords

Healthcare IndustryPharmaceutical IndustryContract Research OrganizationGood Manufacturing Practice (GMP)Good Laboratory Practice (GLP)International Council for Harmonisation (ICH)Real World EvidenceReal World Disease

Tech Stack

Tools & technologies

Google Cloud PlatformTableau

About the role

Key responsibilities & impact

Identify and assess key risks in clinical protocols and study setup, and advise clinical teams on mitigation strategies
Lead reviews of risk areas with Risk Owners to evaluate mitigation progress 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 to R&D Business Partners through Quality Working Groups and Governance Fora
Highlight potential systemic risks to RDQ 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 for quality issues that may require 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 development and follow-up
Coach and mentor team members on Quality Portfolio Review coordination and management
Drive inspection readiness, including inspection narratives, site preparation, key document availability, and mock inspections
Provide front-room and back-room support for Sponsor-Monitor inspections and third-party inspections
Provide remote support for investigational site inspections and post-inspection activities
Supervise and coach others on inspection support and readiness
Provide independent advice on research quality and compliance questions
Support quality integration for acquired assets or companies/partners and execute integration-plan responsibilities
Provide stakeholder guidance, input into Quality Agreements, and support asset divestment
Participate in cross-functional working groups to develop or refine quality processes, tools, and systems
Make independent decisions for compounds and studies with limited supervision
Provide training and coaching to peers and new employees

Requirements

What you’ll need

BA/BSc or equivalent in a scientific, medical, or related discipline
Minimum of 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 styles and global business structures
Up to 10% travel, primarily domestic with some international travel
Preferred: knowledge of GMP, GLP and/or GPvP
Preferred: experience with clinical trial risk management
Preferred: global clinical trial experience
Preferred: experience in Quality Management, Quality Assurance/Control and/or Compliance
Preferred: experience working to 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
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
Inclusive interview process and accommodation support