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Acted as GCP Subject Matter Expert (SME), conducting external audits of investigator sites, CRO vendors, and third-party service providers, ensuring adherence to FDA, EMA, and ICH E6(R2) regulations.
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Performed internal audits across functional areas (clinical operations, data management, pharmacovigilance), identifying compliance risks and supporting remediation through CAPAs.
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Supported regulatory inspections (FDA, EMA, MHRA) by preparing documentation, coordinating teams, facilitating audit interviews, and ensuring inspection readiness.
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Managed the Quality Management System (QMS) by overseeing SOP creation, review, and approval processes; ensured timely document updates in alignment with regulatory changes.
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Assisted with risk-based quality management (RBQM) approaches, applying data-driven methods to identify risk signals and strengthen monitoring plans.
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Monitored and maintained controlled documents, training records, and QA archives, ensuring audit trails and compliance with data integrity principles.
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Participated in vendor qualification audits, assessing clinical laboratories, CROs, and eClinical service providers for compliance with contractual and regulatory requirements.
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Provided compliance training for internal staff and clinical partners, delivering refresher sessions on GCP guidelines, audit readiness, and QMS best practices.
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Investigated and documented protocol deviations, customer complaints, and nonconformances, ensuring proper root cause analysis and timely CAPA implementation.
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Tracked and reported key quality metrics (audit findings, CAPA closure timelines, training completion rates) to management, supporting continuous improvement initiatives.
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Collaborated with study teams to implement inspection readiness checklists and proactive compliance reviews prior to site activation and study milestones.
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Drafted comprehensive audit reports and ensured timely distribution to stakeholders; monitored follow-up activities until closure.
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Supported the maintenance of the CAPA program, verifying the effectiveness of corrective and preventive measures through follow-up reviews and trending analysis.
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Partnered with global QA peers and clinical teams to ensure harmonization of QA practices across multiple regions and clinical programs.
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Provided input during SOP revisions to reflect evolving regulatory requirements and inspection findings, helping maintain alignment with industry standards.