Senior Compliance Specialist – GCP

Thermo Fisher Scientific

Senior Compliance Specialist managing GxP inspections for Thermo Fisher Scientific’s clinical research services. Supporting inspection readiness, CAPAs, risk assessments, and regulatory compliance across the Americas.

Posted 8/20/2026full-timeRemote • North Carolina • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates extensive knowledge of GxP regulations, particularly GCP, and possesses strong experience in managing GxP inspections. Capable of conducting risk assessments, developing mitigation strategies, and providing consultation on inspection readiness and quality assurance matters.

Highest-signal resume keywords

GxP Inspection ManagementGCP KnowledgeRisk AssessmentRoot Cause AnalysisVeeva QMS Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceGxP RegulationsGCP ComplianceDocument ReviewCAPA DevelopmentInspection ReadinessMock InspectionsImpact AnalysisTraining and MentoringNegotiation Skills

Soft Skills

Oral CommunicationWritten CommunicationProblem SolvingCritical ThinkingConflict Management

Tools & Technologies

Veeva QMS

Industry Keywords

Regulatory Authority InspectionsInvestigator SitesQuality Assurance MattersAction ImplementationLessons Learned

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage all aspects of GxP regulatory authority inspections at CRG, investigator sites, and clients
Provide consultation to project teams and clients on GxP inspection readiness, preparation, management, and follow-up
Serve as primary point of contact for client inspection-related discussions
Support inspections of CRG, investigator sites, and sponsors, including preparation, facilitation, hosting, document quality control, post-inspection follow-up, and review of responses to findings
Support mock inspections
Conduct risk assessments and develop mitigation strategies
Train inspection personnel, conduct mock interviews, stage documents, and prepare presentations and storyboards
Support root-cause investigations and development of CAPAs
Follow up on action implementation, effectiveness checks, and supporting evidence
Contribute to lessons-learned discussions and company-wide improvement initiatives
Perform document reviews and other GxP activities supporting project work or company processes
Provide GxP consultation to operational departments and external clients on inspection and quality assurance matters
Mentor and guide junior colleagues

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous 5+ years of quality assurance experience, or equivalent combination of education, training, and experience
Extensive knowledge of GxP, with GCP required
Strong understanding of applicable regional research regulations and guidelines
Experience managing GxP inspections, with GCP inspection experience mandatory
Excellent oral and written communication skills
Strong problem solving, critical thinking, risk assessment, and impact analysis abilities
Above average negotiation and conflict management skills
Confirmed experience in root cause analysis
Ability to multitask and prioritize complex demands/workload
Veeva QMS and auditing experience a plus
Valid driver's license
Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Benefits

Comp & perks

Reasonable accommodation for individuals with disabilities to participate in the job application or interview process and perform essential job functions
Benefits and privileges of employment