Quality Assurance Specialist III

🕒 Maio 28

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Tekton Research

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2006

💊 Farmacêutico

🤝 B2B

🧬 Biotecnologia

💰 Private equity em 2023-10

Pharmaceuticals • B2B • Biotechnology

A Tekton Research é uma organização de pesquisa clínica com múltiplos sites, sediada em Austin, TX, que conduz ensaios clínicos de Fase 1–4 nas áreas de neurociência, doenças cardiometabólicas, doenças infecciosas e medicina geral. A empresa faz parcerias com patrocinadores, CROs e biofarma para desenvolver medicamentos, dispositivos médicos e diagnósticos, operando uma rede de sites de pesquisa liderados por médicos em vários estados dos EUA com rápida ativação de sites, capacidade dedicada de recrutamento de pacientes e alta retenção de participantes. A Tekton enfatiza o cuidado centrado no paciente enquanto oferece escala operacional para ensaios complexos e de grande volume.

Descrição

• 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.

🎯 Requisitos

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field (Master’s degree preferred). • 5–7 years of experience in quality assurance, clinical research, or regulatory compliance, with significant experience in a QA leadership role. • Experience working in a multi-site clinical research organization or network. • In-depth knowledge of GCP, FDA/EMA regulations, ICH guidelines, and clinical trial processes. • Excellent written and oral communication, attention to detail, organizational and planning skills. • Ability to perform and maintain quality work while prioritizing and managing multiple deadlines. • Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint). • Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), or similar platforms. • Proven ability to conduct audits and prepare detailed audit reports. • Demonstrated experience leading audits and managing regulatory inspections.

🏖️ Benefícios

• Must be able to lift to 15 pounds at times • Approximately 50% travel, with the possibility of increased travel during peak periods or as project needs demand. • Prolonged periods of sitting at a desk and working on a computer