QA Compliance Lead Auditor (Host) North Carolina US Remote Based

The QA Compliance Lead Auditor (Host) is a seniorlevel role that is US remote based with preference for candidates near Durham NC location. This position is within Fortreas Global Quality Assurance organization responsible for providing regulatory expertise hosting 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 supports 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

• Coordinate and host business development sponsor qualification routine sponsor audits regulatory inspections and for-cause audit activities including scheduling agendas request lists SME coordination and preparation of audit/inspection support materials.

• Serve as a 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 including preparation meetings document collection interview coordination and issue escalation.
• Facilitate audit and inspection activities as host support or coordinator ensuring requested documentation systems access and subject matter experts are availablein accordance withapplicable procedures.
• Manage receipt triage review and internal routing of external audit reports including coordination of stakeholder review finding assessment response ownership and timelines.
• Review and challenge external audit responses corrective actions and CAPAs to ensure they are adequate complete clearly supported aligned with procedural expectations and responsive to the reported observations.
• Track external audit commitments responses CAPAs evidence and follow-up actions to supporttimelycompletion closure andappropriate escalationof overdue or quality-critical items.
• Support regulatory inspection readiness and for-cause audit coordination by compiling requested informationmaintainingaudit/inspection records and providing status updates to leadership and relevant stakeholders.
• Assistwith cross-training mentoring coaching and/or supervision of auditors audit hosts or audit support staff asrequired.
• Maintain professional and technical knowledge through continuing education review of relevant guidance and publications and participation in professional networks asappropriate; contribute to teamobjectivesand perform other duties as assigned.
• Contribute to the development and interpretation of global QA policies related to regulatory requirements.
• Perform other related duties as assigned.

Minimum Qualifications

• Bachelors 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 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 managementrelated 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 $100000-$115000 / annual

Benefits:All job offers will bebased on a candidates skills and prior relevant experience applicabledegrees/certificationsas well as internal equity and market -timeor 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: August 21 2026

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