This position is within Fortrea’s 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 available in accordance with applicable 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 support timely completion, closure, and appropriate escalation of overdue or quality-critical items.
- Support regulatory inspection readiness and for-cause audit coordination by compiling requested information, maintaining audit/inspection records, and providing status updates to leadership and relevant stakeholders.
- Assist with cross-training, mentoring, coaching, and/or supervision of auditors, audit hosts, or audit support staff as required.
- Maintain professional and technical knowledge through continuing education, review of relevant guidance and publications, and participation in professional networks as appropriate; contribute to team objectives and perform other duties as assigned.
- Contribute to the development and interpretation of global QA policies related to regulatory requirements.
- Conduct internal audits as directed, such as process/system and service provider quality assessment for qualification/requalification
- 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 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 Include:
- Postgraduate degree (MSc or equivalent) in a scientific or management‑related discipline.
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.
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