Senior Specialist, QA Clinical Auditor

Johnson & Johnson

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

Posted 9/30/2026full-timeSão Paulo • BrazilSeniorWebsite

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 and leading clinical quality assurance audits. Proficient in data analysis, report writing, and project management within the clinical trial environment.

Highest-signal resume keywords

GCP Audit LeadershipClinical Quality Assurance AuditsRegulatory Inspection SupportData Analysis and InterpretationProject 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 KnowledgeClinical Trial OperationsAudit Planning and ConductData AnalyticsRisk ManagementRegulatory Standards InterpretationStandard Operating Procedures ManagementDocumentation PracticesAudit Tools ProficiencyCAPA Management

Soft Skills

Conflict ResolutionNetworking SkillsRelationship BuildingTime ManagementFlexibility

Tools & Technologies

Data Analytics ToolsStandard Applications/Systems

Industry Keywords

Drug Development ProcessFDA RegulationsEU CTRICH E6 R3Clinical Trial Risk 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
Conduct due diligence, for-cause, cross-functional, and complex or sensitive system/service-provider audits
Ensure standard procedures, audit tools, and audit plans are understood and applied
Analyze and interpret data and identify patterns and trends in datasets
Ensure timely and appropriate review and delivery of CAPAs and audit actions
Present information logically and concisely in verbal and written formats, including clear report writing
Support GCP audit strategy, especially risk-based auditing approaches and audit plans
Support regulatory inspections in various roles
Complete assigned training requirements on time to maintain inspection readiness
Assist with preparation of training materials when requested
Participate in assigned projects and teams
Meet priorities, checkpoints, and timelines to achieve project progress

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 trial operations, or a related space
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, including FDA regulations, EU CTR, and ICH E6 R3
Understanding of fundamentals of clinical trial risk management
Broad knowledge of management of standard operating procedures, good documentation practices, and records management
Digital literacy and analytics experience using standard applications/systems and data analytics tools
Ability to plan and prioritize work efficiently and work well under time constraints
Flexibility to respond to changing business needs
Familiarity with new and emerging technologies and analytics, and ability to identify opportunities for creative capabilities within QA audit processes
Experience conducting Clinical Quality Assurance audits
Ability to interpret global regulatory standards
Inspection support experience with FDA, EMA, and other inspectorates
Conflict resolution/management skills
Strong networking and relationship-building skills
Experience balancing multiple projects simultaneously
Must be able to speak and write in English (Advanced/Fluent)

Benefits

Comp & perks

Hybrid Work / J&J Flex way of working
Inclusive work environment
Up to 30% domestic and/or international travel