legal
Posted 22 hours agoQA Compliance Lead Auditor (GCP Auditor) North Carolina Hybrid Based
at Fortrea
Hybrid
Responsibilities
- Facilitate and review audit and inspection responses, including oversight of CAPA development and implementation.
- 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.
- Ensure Regulatory Compliance and Quality Assurance (RC & QA)
Requirements
- This position is within Fortrea’s Global Quality Assurance organization, responsible for providing regulatory expertise, leading complex GCP audits and inspections, and driving global quality initiatives.
- The role contributes to global QA policy development, leads and/or participates in conduct of risk-based GCP audits, supports audit hosting and inspection response activities, leads quality metrics reporting, and participates in continuous improvement initiatives across the QA organization.
- 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.
- Qualifications 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. Required
- experience in a regulated environment, including GxP roles.
- Demonstrated regulatory expertise with detailed knowledge of GCP and applicable global regulations .
- Experience leading or contributing to quality and process improvement initiatives reducing inspection risks and strengthen inspection readiness. Preferred
- Qualifications Postgraduate degree (MSc or equivalent) in a scientific or management‑related discipline.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Benefits
- Pay Range: USD $105,000-$120,000
- Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
- benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Flexible time off (FTO).
Additional details
- The QA Compliance Lead Auditor (GCP Auditor) is a senior‑level role that is US remote based with preference for candidates near Durham, NC location .
- This position serves as a regulatory subject matter expert (SME), supporting internal teams, clients, and regulatory authority interactions to ensure ongoing compliance and inspection readiness.
- The position also acts as a backup to QA Management and supports operational reporting responsibilities. Key
- Contribute to the development and interpretation of global QA policies related to regulatory requirements.
- Act as backup to the QA Manager as required and provide monthly activity reporting.
- responsibilities defined in applicable controlled documents are followed. Perform other related duties as assigned. Minimum
- Strong strategic communication skills with clients and internal stakeholders.
- Applicants must be legally entitled to work in US without the need for employer-sponsored work permits.
- Work Environment: Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations with occasional travel both domestic and international. Physical