QA Compliance Lead Auditor (Host)

Fortrea Development India; Bengaluru; In loco; INR 2.500.000 - 4.000.000; Tempo pieno

Descrizione del lavoro

Fortrea Development India seeks a regulatory SME within its Global Quality Assurance organization. The role provides regulatory expertise, hosts complex GCP audits and inspections, and drives global quality initiatives to ensure ongoing compliance and inspection readiness.

The position leads or supports audit hosting, quality metrics, and continuous improvement, acting as a backup to QA management and contributing to cross-functional regulatory activities. Travel is occasional.

Competenze

• Bachelor's degree in a relevant scientific discipline.
• Fluent in English, written and verbal.
• 8 years of experience in a regulated environment with GxP.
• Regulatory expertise with detailed knowledge of GCP and global regulations.
• Lead GCP Auditor with strong risk-based assessment skills.
• Strong strategic communication with clients and internal stakeholders.
• Experience leading quality and process improvement initiatives to reduce inspection risks.

Mansioni

• Coordinate and host audits and inspections, including scheduling, agendas, request lists, SME coordination, and preparation of materials.
• Serve as primary contact for external auditors, sponsors, inspectors, internal stakeholders, and operational teams throughout the audit/inspection lifecycle.
• Prepare for readiness meetings, document collection, interviews, and issue escalation during audits/inspections.
• Facilitate audit/inspection activities as host, support, or coordinator, ensuring documentation and SME availability.
• Manage receipt, triage, review, and routing of external audit reports, findings, and CAPAs.
• Review and challenge external audit responses and CAPAs for adequacy and alignment with procedures.
• Track commitments, responses, CAPAs, and follow-up actions to ensure timely closure and escalation of overdue items.
• Support regulatory inspection readiness and provide status updates to leadership and stakeholders.
• Assist with cross-training, mentoring, and supervision of auditors and staff as needed.
• Maintain professional knowledge and contribute to global QA policy development.
• Conduct internal audits such as process/system and service provider quality assessments as directed.

Conoscenze

Regulatory expertise

Lead GCP Auditor

Risk-based assessment

Strategic communication

Formazione

Bachelor's degree in Pharmacy, Chemistry, Biology

Descrizione del lavoro

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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