GCP QA Auditor III

Thermo Fisher Scientific

. Lead complex and/or multi-department internal and external audits .

Posted 11/9/2026full-timeRemote • Texas • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of Good Clinical Practice (GCP) and regulatory compliance, with a strong ability to lead audits and develop strategies for quality assurance. Proven skills in root cause analysis, risk assessment, and effective communication with clients and project teams.

Highest-signal resume keywords

GCP Quality Assurance ExperienceInternal and External AuditsRoot Cause AnalysisRegulatory ComplianceProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP KnowledgeTechnical Document ReviewDatabase AuditsClinical Study Report AuditsProcess Improvement ActivitiesAudit Report PreparationQuality Assurance ResourceVendor AuditsRisk AssessmentImpact Analysis

Soft Skills

Excellent Communication SkillsProblem SolvingNegotiation SkillsConflict ManagementMultitasking

Industry Keywords

Quality Assurance ProcessesRegulatory GuidelinesClient Contractual ObligationsAudit Findings PresentationMentorship

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead complex and/or multi-department internal and external audits
Ensure compliance with quality assurance processes, standards, global regulatory guidelines and client contractual obligations
Identify quality and regulatory compliance issues and determine root causes of non-conformance
Develop strategies to address quality and compliance issues
Perform technical document reviews and other GCP activities
Conduct or lead client, internal and GCP audits and regulatory inspections
Lead site, facility, vendor and subcontractor audits
Provide GCP consultation and support to project teams and external clients
Lead process audits and participate as co-auditor in complex system audits
Perform database audits, clinical study report audits, sample results table audits and process improvement activities
Serve as a quality assurance resource to operational departments
Prepare and present audit findings at departmental, internal operations and client meetings
Provide mentorship and guidance to junior auditors
Prepare finished audit reports for management
Plan and deliver billable quality services for clients and projects
Serve as a client contact when needed

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous GCP QA experience comparable to 5+ years
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
Detailed knowledge of GCP and appropriate regional research regulations and guidelines
Demonstrated proficiency in project-based or internal GCP audits and vendor audits
Excellent oral and written communication skills
Strong problem solving, risk assessment and impact analysis abilities
Solid experience in root cause analysis
Above average negotiation and conflict management skills
Ability to multitask and prioritize competing demands/workload
Valid driver's license
Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Benefits

Comp & perks

Global team environment
Collaboration and development opportunities
Scientific excellence-focused work environment