Tekton Research

• Conduct in-depth internal audits of clinical research activities, including investigator site files, informed consent processes, source documentation, and data integrity. • Evaluate compliance with GCP, ICH guidelines, FDA/EMA regulations, and sponsor requirements. • Oversee inspection readiness activities, including mock inspections, and act as a QA representative during regulatory inspections. • Identify, evaluate, and manage quality risks across the site network, prioritizing areas for mitigation. • Develop and oversee quality improvement plans to address systemic risks. • Lead root cause analyses and the development of complex Corrective and Preventive Action (CAPA) plans. • Monitor CAPA implementation, ensure effectiveness, and report outcomes to senior leadership. • Design and implement site-wide quality improvement initiatives, ensuring alignment with industry best practices. • Develop and update Standard Operating Procedures (SOPs), work instructions, and quality manuals. • Provide QA team members and clinical staff with advanced quality assurance, regulatory compliance, and auditing training. • Mentor junior and mid-level QA professionals, supporting their development and growth within the organization. • Act as a subject matter expert in regulatory requirements, providing guidance to clinical operations, regulatory affairs, and other stakeholders. • Collaborate with internal and external stakeholders to address quality-related issues and ensure trial integrity. • Prepare comprehensive audit reports and executive summaries for leadership review. • Analyze quality metrics to identify trends, opportunities for improvement, and areas of excellence.