QA Compliance Lead Auditor (GCP) North Carolina area Remote Based

Fortrea; North Carolina; Remoto; USD 70.000 - 125.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

Life insurance

STD/LTD

401(k)

Flexible time off

Descrizione del lavoro

Fortrea seeks a QA Compliance Lead Auditor for a US remote role, preferably near Durham, NC, within the Global Quality Assurance organization.

You will lead complex GCP audits, provide regulatory SME guidance, and drive global quality initiatives, ensuring inspection readiness and strong client interactions.

Competenze

• 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.

Mansioni

• Lead risk-based, end-to-end GCP audits and inspections across study sites and vendors.
• Provide regulatory guidance to internal teams, clients, and regulatory authorities.
• Coordinate sponsor qualification audits, inspections, and host activities.
• Serve as primary QA contact throughout the audit lifecycle and manage requests, access, and escalations.
• Review responses and CAPAs to ensure corrective actions address observations.
• Track commitments, CAPAs, and supporting evidence to closure.
• Maintain and apply knowledge of QMS and quality issue management.
• Mentor and train auditors and audit hosts as appropriate.
• Support QA relationships with strategic clients and drive global quality initiatives.
• Ensure activities comply with regulatory requirements and controlled documents.

Conoscenze

GCP audits

Regulatory expertise

QA metrics reporting

Client & regulatory liaison

Formazione

Bachelor's degree in Pharmacy/ Chemistry/ Biology

Descrizione del lavoro

The QA Compliance Lead Auditor is a senior-level role that is US remote based with preference for candidates near Durham, NC location. 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. 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 role contributes to global QA policy development, leads and/or participates in conduct of risk-based GCP audits, leads and/or supports end-to-end audit/inspection hosting and response activities, leads quality metrics reporting, and participates in continuous improvement initiatives across the QA organization. The position also acts as a backup to QA Management and supports operational reporting responsibilities.

Key Responsibilities

• Conduct and lead risk-based, end-to-end GCP audits, including process, service provider/vendor, clinical investigator site, study, and for-cause audits.
• Provide GCP subject matter expertise and regulatory guidance to internal stakeholders, project teams, and clients, including client- and regulatory authority-facing support as appropriate.
• Coordinate and host sponsor qualification and routine audits, regulatory inspections, for-cause audits, and other external audit activities.
• Serve as a primary QA point of contact throughout the audit and inspection lifecycle, supporting readiness, request management, document and system access, SME and interview coordination, and issue escalation.
• Facilitate and review audit and inspection responses, including assessment and challenge of responses, corrective actions, and CAPAs to ensure they adequately address reported observations.
• Track audit and inspection commitments, CAPAs, supporting evidence, and follow-up activities through completion and closure, escalating significant or overdue items as appropriate.
• Maintain a strong working knowledge of the Quality Management System (QMS) and support the timely progression, tracking, escalation, and closure of quality issues and associated CAPAs.
• Support QA-to-QA relationships with key strategic clients.
• Lead or support quality metrics, trend reporting, Quality Reviews, and global Quality initiatives focused on compliance, consistency, and efficiency.
• Contribute to the development and interpretation of global QA policies and ensure activities are conducted in accordance with applicable regulatory requirements and controlled documents.
• Deliver audit-related training and provide cross-training, mentoring, and coaching to auditors, audit hosts, and audit support staff, as appropriate.
• Maintain current professional and technical knowledge through continuing education, regulatory guidance, relevant publications, and professional networks.
• Perform other related duties as assigned.

Minimum 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

• 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 understanding of Quality Management Systems (QMS), quality issue management, and CAPA processes, including tracking issues and actions through timely resolution and closure.
• 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 Qualifications

• Postgraduate degree (MSc or equivalent) in a scientific or management-related discipline.

Applicants must be legally entitled to work in US without the need for employer-sponsored work permits. This position is not eligible for sponsorship.

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 Requirements

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• 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.
• Regular and consistent attendance.
• Varied hours may be required.

Pay Range: USD $70,000-$125,000

Benefits: All job offers will bebased on a candidate's skills and prior relevant experience, applicabledegrees/certifications,as well as internal equity and market data.Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Flexible time off (FTO).

Application Deadline: 11/08/26

Learn more about our EEO & Accommodations request here.