QA Compliance Lead Auditor – Host

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $100k - $115k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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

• 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

• 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