QA Compliance Lead Auditor – Host

Fortrea

QA compliance lead auditor hosting complex GCP audits and regulatory inspections for Fortrea’s global quality-assurance organization. Driving inspection readiness, CAPA oversight, metrics reporting, and QA policy initiatives.

Posted 8/19/2026full-timeRemote • North Carolina • 🇺🇸 United StatesSenior💰 $100,000 - $115,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates expertise in coordinating audits and inspections within regulated environments, with a strong focus on GCP compliance and quality improvement initiatives. Proficient in strategic communication and stakeholder management to ensure operational readiness and effective audit responses.

Highest-signal resume keywords

Lead GCP AuditorGCP KnowledgeRegulatory Inspection ReadinessQuality Improvement InitiativesCritical Thinking Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Audit CoordinationRegulatory ComplianceCAPA ManagementDocument CollectionRisk-Based AssessmentQuality Metrics ReportingStakeholder ManagementAudit Record MaintenanceInspection Lifecycle ManagementScientific Degree

Soft Skills

Strategic CommunicationMentoringCoachingCritical ThinkingTeam Collaboration

Tools & Technologies

Computer SoftwareAudit Management Systems

Industry Keywords

GxPGCPRegulated EnvironmentQuality AssuranceAudit Activities

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Coordinate and host business development, sponsor qualification, routine sponsor audits, regulatory inspections, and for-cause audit activities
Schedule audits and inspections, prepare agendas and request lists, coordinate SMEs, and prepare support materials
Serve as primary point of contact for external auditors, sponsors, inspectors, internal stakeholders, and operational teams throughout the audit or inspection lifecycle
Support operational team readiness before, during, and after external audits and inspections
Coordinate preparation meetings, document collection, interview coordination, and issue escalation
Facilitate audit and inspection activities as host, support, or coordinator
Ensure requested documentation, systems access, and subject matter experts are available according to applicable procedures
Manage receipt, triage, review, and internal routing of external audit reports
Coordinate stakeholder review, finding assessment, response ownership, and timelines
Review and challenge external audit responses, corrective actions, and CAPAs
Track audit commitments, responses, CAPAs, evidence, and follow-up actions through completion and closure
Support regulatory inspection readiness and for-cause audit coordination
Compile requested information, maintain audit/inspection records, and provide status updates to leadership and stakeholders
Assist with cross-training, mentoring, coaching, and/or supervision of auditors, audit hosts, or audit support staff
Maintain professional and technical knowledge through continuing education, relevant guidance and publications, and professional networks
Contribute to global QA policy development and interpretation related to regulatory requirements
Contribute to team objectives and perform other related duties as assigned
Act as backup to QA Management and support operational reporting responsibilities
Lead quality metrics reporting and participate in continuous improvement initiatives across the QA organization

Requirements

What you’ll need

Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline
Relevant and equivalent experience may be considered in lieu of formal education
Fluent in English, written and verbal
Minimum 8 years of experience in a regulated environment, including GxP roles
Detailed knowledge of GCP and applicable global regulations
Experienced Lead GCP Auditor
Strong critical thinking and risk-based assessment skills
Strong strategic communication skills with clients and internal stakeholders
Experience leading or contributing to quality and process improvement initiatives reducing inspection risks and strengthening inspection readiness
Postgraduate degree (MSc or equivalent) in a scientific or management-related discipline preferred
Must be legally entitled to work in the US without employer-sponsored work permits
Position is not eligible for sponsorship
Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Ability to lift and carry objects including luggage and laptop computer, maximum 15–20 lbs.
Regular and consistent attendance
Varied hours may be required

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Life insurance
Short-term disability (STD)
Long-term disability (LTD)
401(K)
Flexible time off (FTO)
Comprehensive benefits for eligible regular full-time or part-time employees working 20 or more hours per week