Fortrea · 3 weeks ago
QA Compliance Lead Auditor (GCP Auditor) North Carolina / US Remote Based
United States
Full-time
Remote
Senior Level
$105K/yr - $120K/yr
8+ years expFortrea is a company focused on global quality assurance, and they are seeking a QA Compliance Lead Auditor (GCP Auditor) to join their team. This senior-level role involves providing regulatory expertise, leading GCP audits, and driving global quality initiatives to ensure compliance and inspection readiness.
BiotechnologyHealthcareClinical TrialsHealth Care
No H1B
Responsibilities
Conduct risk-based end-to-end GCP audit activities, i.e., process, service provider/vendor, clinical investigator site, study, for cause audits
Provide GCP subject matter expertise and lead/influence the Clinical Development organization by providing guidance and client/authority facing support on specific niche regulatory topics to internal stakeholders, project teams and clients
Facilitate and review audit and inspection responses, including oversight of CAPA development and implementation
Contribute to the development and interpretation of global QA policies related to regulatory requirements
Support project teams in CAPA plan creation and execution
Support QA‑to‑QA relationships with key strategic clients
Lead or support reporting of quality metrics and trends via Monthly Reports, Quality Reviews, and Liaison Meetings
Manage (for area of expertise) or participate (for multi‑regulatory topics) in global Quality initiatives aimed at improving compliance and efficiency
Deliver audit‑related training, including basic, intermediate, and complex audit methodologies
Act as backup to the QA Manager as required and provide monthly activity reporting
Ensure Regulatory Compliance and Quality Assurance (RC & QA) responsibilities defined in applicable controlled documents are followed
Perform other related duties as assigned
Qualification
Required
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
Demonstrated regulatory expertise with detailed knowledge of GCP and applicable global regulations
Experienced Lead GCP Auditor with 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 strengthen inspection readiness
Preferred
Postgraduate degree (MSc or equivalent) in a scientific or management‑related discipline
Benefits
Medical
Dental
Vision
Life
STD/LTD
401(K)
Flexible time off (FTO)
Company
Fortrea
Fortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Anshul Thakral
Chief Executive Officer
Agnieszka Gallagher
General Counsel, Chief Compliance Officer and Corporate Secretary
Recent News
2026-08-02
2026-07-29
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