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 robust 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. Learn more about our EEO & Accommodations request here.

📌 QA Compliance Lead Auditor (Bengaluru)
🏢 Fortrea
📍 Bengaluru