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 develop 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 aligned with industry best practices • Develop and update Standard Operating Procedures (SOPs), work instructions, and quality manuals • Provide advanced quality assurance, regulatory compliance, and auditing training to QA team members and clinical staff • Mentor junior and mid-level QA professionals • Act as a subject matter expert in regulatory requirements and advise 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, improvement opportunities, and areas of excellence • Perform other duties as assigned