QA Engineer

• Provide overall strategic oversight for global GCP, GVP, & GLP QA activities, ensuring collaborative and compliant implementation of initiatives with all internal and external partners.
• Act as a senior strategic partner to Clinical Development, Pharmacovigilance, and Non-Clinical leadership.
• Lead and provide technical direction for all Health Authority inspections (GCP, GVP, GLP), including preparation, hosting, and ensuring robust and timely responses to any findings.
• Develop and execute the risk-based GCP/GVP/GLP audit strategy for all internal processes, investigator sites, and external service providers, and oversee the execution of the comprehensive audit program.
• Drive continuous improvement by leveraging QMS data, monitoring KPIs, and analysing risk.
• Oversee the CAPA process to ensure effective solutions and maintain all GCP/GVP/GLP QA processes, standards, and the associated compliance training program.
• Implement risk-based quality approaches for clinical development programs and provide ongoing quality risk monitoring.
• Monitor major regulatory updates and industry trends, benchmarking through professional consortia and networking to identify and lead necessary change management opportunities.

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