Manager, Clinical Quality Risk Management

Johnson & Johnson

Manager overseeing Clinical Quality Risk Management at Johnson & Johnson. Responsible for GxP Quality Management System and ensuring compliance in clinical trials.

Posted 6/17/2026full-timeIrvine • California, Florida • 🇺🇸 United StatesMid-LevelSenior💰 $102,000 - $177,100 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support the Clinical Quality Risk Management (CQRM) objectives, overseeing a robust GxP Quality Management System to enable a diverse portfolio of medical device products and services.
Serve as the clinical quality point of contact to support clinical trial risk assessments, Integrated Quality Plans (IQP), risk mitigations, inspections, and provide guidance to ensure compliance with Good Clinical Practices (GCP), external regulations/requirements, and internal J&J Vision procedures.
Function as a subject matter authority for GCP for J&J Vision and be responsible for supporting, or leading as assigned, quality initiatives.
Serve as a clinical quality point of contact for inspections, IQP and clinical study/program compliance concerns/escalation.
Provide clinical quality oversight in support of the J&J Vision MedTech business to ensure compliance with applicable GCP regulatory requirements, J&J Standards, and applicable SOPs.
Establish routine presentation of clinical risk and compliance trends and metrics to business partners.
Develop and manage proactive risk management strategies in coordination with R&D clinical business partners.
Support the Vision Quality Management System (QMS) to ensure alignment with the MedTech strategies and policies and evolving industry and regulatory demands related to Good Clinical Practice and Clinical Risk Management.
Collaborate with Clinical R&D to ensure that investigational sites and external service providers supporting J&J Vision clinical studies have appropriate support for the management of third-party inspections.

Requirements

What you’ll need

A minimum of a Bachelors or equivalent University degree is required with a focus degree in scientific discipline or business preferred
Five to seven (5-7) years of Clinical research or Clinical quality related experience
Experience in a medium to large scale, life sciences organization.
Medical device/MedTech industry or equivalent healthcare industry experience
Strong working knowledge of GCP, ISO14155, ICH-GCP, 21CFR Part 11, 21 CFR 812 and other relevant standards and regulations for clinical research.
Health authority inspection experience is desirable.
Innovative mindset to build and maintain a competitive advantage
Conflict resolution, management, and negotiation skills
Outstanding written and verbal communications skills in English
Strong project management and execution skills
Ability to interpret data to develop action plans as part of risk mitigation and / or continuous improvements.

Benefits

Comp & perks

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)).
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Good Clinical Practices (GCP)ISO 14155ICH-GCP21 CFR Part 1121 CFR 812Clinical researchRisk managementQuality Management System (QMS)Data interpretationProject management

Soft Skills

Conflict resolutionManagement skillsNegotiation skillsWritten communicationVerbal communicationInnovative mindsetExecution skillsCollaborationLeadershipOrganizational skills