Senior Specialist, Quality Assurance Clinical Auditor

Johnson & Johnson

. Independently lead the planning, conduct, and reporting of GCP QA routine audits.

Posted 10/30/2026full-timeUnited StatesSenior💰 $94,000 - $151,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Good Clinical Practices (GCP) and regulatory compliance, with a strong background in conducting Clinical Quality Assurance audits and analyzing data trends. Proficient in developing audit strategies and ensuring adherence to corporate policies and standards.

Highest-signal resume keywords

GCP Audit Strategy SupportClinical Quality Assurance AuditsData Analysis and InterpretationRegulatory Compliance KnowledgeClinical Trial Risk Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

GCP KnowledgeAuditingData AnalyticsClinical OperationsRegulatory RequirementsStandard Operating Procedures ManagementGood Documentation PracticesRecords ManagementClinical Investigator Site AuditsCAPA Management

Soft Skills

Effective CommunicationTime ManagementFlexibilityPrioritizationTeam Collaboration

Tools & Technologies

Data Analytics ToolsStandard ApplicationsAudit Tools

Industry Keywords

Drug Development ProcessFDA RegulationsEU CTRICH E6 R2Clinical Trial Management

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Independently lead the planning, conduct, and reporting of GCP QA routine audits.
Support non-routine GCP audits, including Clinical Investigator Site, Trial/Program, External Service Provider, Process/System, and Local Operating Country audits.
Ensure adherence to corporate policies, internal standards/requirements, and applicable regulatory requirements.
Ensure standard procedures, audit tools, and audit plans are understood and applied.
Analyze and interpret data and identify patterns and trends in data sets.
Ensure timely and appropriate review and delivery of CAPAs and audit actions.
Present information logically and concisely verbally and in writing, including writing clear reports.
Provide GCP Audit strategy support, especially for QA risk-based auditing approaches and audit plans.
Support regulatory inspections in various roles.
Complete assigned training requirements to maintain inspection readiness.
Assist in preparing training materials when requested.
Participate in projects or teams as assigned by the supervisor.
Meet priorities, checkpoints, and timelines for work and projects.

Requirements

What you’ll need

A minimum of a Bachelor's degree is required.
A minimum of 5 years of related work experience in auditing, clinical operations, or other key related area
Knowledge of the drug development process, applicable regulations, R&D practices, and scientific and quality terminology.
Knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g. FDA regulations, EU CTR, ICH E6 R2)
Experience conducting Clinical Quality Assurance audits or assessments of clinical investigator sites, studies, or systems
Understanding of fundamentals of clinical trial risk management.
Broad knowledge of management of standard operating procedures, good documentation practices, and records management.
Digital literacy & Analytics - Experience using standard applications/systems & data analytics tools.
Ability to plan and prioritize work in an efficient manner, and to work well under time constraints.
Flexibility to respond to changing business needs.
Must be able to speak and write in English.
May require up to 30% domestic and/or international travel.

Benefits

Comp & perks

Retirement plan (pension)
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Hybrid work arrangement
Equal employment opportunity and inclusive interview process
Disability accommodation support