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Manager, Clinical Risk Management
Quality
Spring House / Raritan / Titusville / United States of America
Manager, Clinical Risk Management
Apply now
Save
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Job title
Manager, Clinical Risk Management
Function
Quality
Sub function
Clinical Quality
Category
Manager, Clinical Quality (P7)
Location
Spring House / Raritan / Titusville / United States of America
Date posted
May 13 2026
Requisition number
R-074849
Work pattern
Hybrid Work
This job posting is anticipated to close on May 20 2026. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Quality
Job Sub Function:
Clinical Quality
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:
Johnson & Johnson is currently seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R D Quality CRM team located at a J&J office in Spring House, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium; and Basel, Switzerland.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
US- Requisition Number: R-074849
Belgium - Requisition Number: R-076146
Switzerland - Requisition Number: R-076148
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Job description to follow:
The Manager, Cross TA Clinical Risk Management, works with the trial teams and/or Program teams to coordinate the identification, assessment, and mitigation of quality risks that could impact on trial data integrity, patient safety, well - being, or rights. Throughout the duration of the trial/program, this Manager executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.
Key responsibilities:
Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.
Leads regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned).
Maintains CQP (Clinical Quality Plans) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations
Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews
Communicates and facilitates risk updates to R D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).
Highlight new potential systemic risk to RDQ CRM management.
Develops and ensures a consistent interpretation of issues that require quality investigations
Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R D management.
In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)
Drives ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
Provides support for Investigator, Sponsor-Monitor and third-party inspections including post inspection support
Provides independent advice on questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.
Qualifications:
A minimum of a Bachelor's degree (scientific, medical, or related discipline) is required.
A minimum of 8 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required.
Proven strong GCP Quality and/or clinical trials experience is required.
Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross-functional team environment is required.
Flexibility to respond to changing business needs is required.
Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
Proficiency in Microsoft Office Applications is required.
Experience with fundamentals of clinical trial risk management is preferred.
Experience working to ICH guidelines is preferred.
Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred.
Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred.
Strong Project Planning/Management skills is preferred.
Experience in managing escalations and CAPA support/advisement is preferred.
Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related) to analyze/interpret collective data and provide insights to drive decision-making is preferred.
Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
Requires proficiency in speaking and writing English.
Up to 10% travel, primarily domestic with some international travel.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$102,000.00 - $177,100.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: -
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Medicines & therapies
Medical devices & technology
Media
Contact
View saved jobs
0
English
Login
Healthcare areas
News
Investors
Careers
Our company
Search J&J.com
Home
Careers
Jobs
Manager, Clinical Risk Management
Quality
Spring House / Raritan / Titusville / United States of America
Manager, Clinical Risk Management
Apply now
Save
Share job
Job title
Manager, Clinical Risk Management
Function
Quality
Sub function
Clinical Quality
Category
Manager, Clinical Quality (P7)
Location
Spring House / Raritan / Titusville / United States of America
Date posted
May 13 2026
Requisition number
R-074849
Work pattern
Hybrid Work
This job posting is anticipated to close on May 20 2026. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Quality
Job Sub Function:
Clinical Quality
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:
Johnson & Johnson is currently seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R D Quality CRM team located at a J&J office in Spring House, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium; and Basel, Switzerland.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
US- Requisition Number: R-074849
Belgium - Requisition Number: R-076146
Switzerland - Requisition Number: R-076148
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Job description to follow:
The Manager, Cross TA Clinical Risk Management, works with the trial teams and/or Program teams to coordinate the identification, assessment, and mitigation of quality risks that could impact on trial data integrity, patient safety, well - being, or rights. Throughout the duration of the trial/program, this Manager executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.
Key responsibilities:
Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.
Leads regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned).
Maintains CQP (Clinical Quality Plans) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations
Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews
Communicates and facilitates risk updates to R D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).
Highlight new potential systemic risk to RDQ CRM management.
Develops and ensures a consistent interpretation of issues that require quality investigations
Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R D management.
In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)
Drives ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
Provides support for Investigator, Sponsor-Monitor and third-party inspections including post inspection support
Provides independent advice on questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.
Qualifications:
A minimum of a Bachelor's degree (scientific, medical, or related discipline) is required.
A minimum of 8 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required.
Proven strong GCP Quality and/or clinical trials experience is required.
Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross-functional team environment is required.
Flexibility to respond to changing business needs is required.
Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
Proficiency in Microsoft Office Applications is required.
Experience with fundamentals of clinical trial risk management is preferred.
Experience working to ICH guidelines is preferred.
Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred.
Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred.
Strong Project Planning/Management skills is preferred.
Experience in managing escalations and CAPA support/advisement is preferred.
Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related) to analyze/interpret collective data and provide insights to drive decision-making is preferred.
Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
Requires proficiency in speaking and writing English.
Up to 10% travel, primarily domestic with some international travel.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$102,000.00 - $177,100.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: -
Similar jobs
Manager, Clinical Risk Management
Quality
Beerse
Save
Manager, Clinical Risk Management
Quality
Allschwil
Save
Director, Clinical Sciences, Oncology
Discovery & Pre-Clinical/Clinical Development
Spring House / Raritan
Save
Careers in North America
Discover career opportunities at J&J locations in the United States and Canada.
Not ready for a new role right now?
No worries. Join our talent community and we'll reach out when we post new jobs that may match your interests and skills so you can apply when the time is right.
Locations
North America
Europe, Middle East & Africa
Asia Pacific
Latin America
Medicines & therapies
Products
Oncology
Neuroscience
Immunology
Cardiopulmonary
Medical devices & technology
Products
Cardiovascular
Orthopaedics
Surgery
Vision
About us
Our company
Medicines & therapies
Medical devices & technology
Careers
Investors
Media
Key links
Terms of use
Privacy
Cookie policy
Customize Cookie Settings
Request disability accommodation
Hiring FAQs
Employment policies
E-Verify
Recruitment fraud notice
Get in touch
Contact us
Equal Employment Opportunity Posters | GINA Supplement
Do not sell or share my personal information
Limit the use of my sensitive personal information
Johnson & Johnson and its affiliates 2026
JnJ.com Survey Invitation - press escape to dismiss
We are looking for ways to improve the JNJ.com experience.
Do you have a few minutes to complete our short survey?
Not at this time
Yes, I can help
(Survey opens in new window)
Please note that by clicking this link, you'll be leaving jnj.com and going to a third-party website not governed by the JNJ.com privacy policy.
Job ID: 521493311
Originally Posted on: 5/17/2026
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