Senior Specialist, Clinical Risk Management

Johnson & Johnson

Senior Specialist supporting Clinical Quality Risk Management for J&J Vision overseeing GxP Quality Management System and clinical trial compliance. Ensuring adherence to Good Clinical Practices and facilitating quality initiatives.

Posted 7/15/2026full-timeIrvine • California, Florida • 🇺🇸 United StatesSenior💰 $94,000 - $151,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Good Clinical Practices (GCP) and Quality Management Systems (QMS) within the Medical Device industry, ensuring compliance with regulatory standards and leading cross-functional teams to drive quality initiatives and risk management strategies.

Highest-signal resume keywords

Good Clinical Practice (GCP)Quality Management System (QMS)Regulatory ComplianceClinical Research ExperienceProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ISO14155:2020ICH-GCP21CFR Part 1121 CFR 812Clinical Quality Risk ManagementRisk AssessmentQuality InitiativesData AnalysisCompliance TrendsStakeholder Engagement

Soft Skills

LeadershipCollaborationCommunicationMotivationProblem Solving

Tools & Technologies

Microsoft WordMicrosoft PowerPointMicrosoft ExcelMicrosoft OutlookInternet ExplorerChrome

Industry Keywords

Medical DeviceMedTechClinical QualityLife SciencesHealth Authority Inspection

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

The Sr. Specialist, Clinical Quality Risk Management works to 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.
This individual serves 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 to clinical business partners to ensure compliance with applicable GCP regulatory requirements, J&J Standards, and applicable J&J Vision SOPs.
Establish routine presentation of compliance trends and metrics to business partners and help champion organizational performance and improvements measures.
Develop and manage proactive risk management strategies in coordination with R&D leaders.
Collaborate with Clinical R&D to ensure that investigational sites and external service providers supporting JNJ studies have appropriate support for the management of third-party inspections.
Oversee the Quality Management Systems (QMS) so that it fits in seamlessly with the MedTech strategies and policies and evolving industry and regulatory demands.
Assist the Franchise Head with interdepartmental and cross-functional strategic planning and budget management.
Report to and work in close collaboration with the Franchise Director(s) and Quality Assurance and other quality functions to develop and implement effective GCP quality programs across the Franchises.

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, ISO14155:2020, ICH-GCP, 21CFR Part 11, 21 CFR 812 and other relevant standards and regulations for clinical research.
Health authority inspection experience is desirable.
Ability to motivate colleagues and collaborators at all levels of the organization.
Demonstrated experience establishing collaborative relationships and leading cross functional teams to deliver results.
Innovative approach to build and maintain a competitive advantage.
Requires a minimum of 5 years work experience within clinical research or clinical quality related function.
Experience working in the Medical Device industry is required.
A thorough understanding and experience with the application of Good Clinical Practice (GCP) and Quality System Regulation is required.
Regulatory/ Health Authority inspection experience
Experience engaging with and establishing stakeholder relationships.
Decision making, prioritization, and ability to lead cross-functional teams.
Experience and proficiency with basic office software tools (e.g., Microsoft Word, PowerPoint, Excel, Outlook) and internet browsers (e.g., Internet Explorer, Chrome) are required.
Excellent verbal and written communication skills, including presentation skills
Project management savvy, problem solving, possesses business/financial acumen, and process excellence understanding of methodologies.

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
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year