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About the Role

The Quality Assurance (QA) Specialist III is a senior-level professional responsible for leading and advancing quality assurance efforts across a clinical research site network. This role involves overseeing complex audits, driving process improvement initiatives, managing compliance risks, and serving as a key resource for regulatory readiness. The QA Specialist III acts as a subject matter expert (SME) in clinical research compliance, providing strategic guidance to ensure the integrity of clinical trials and alignment with regulatory requirements.

Responsibilities

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.
Other duties as assigned

Requirements

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.
Experience working in a multi-site clinical research organization or network.
Prolonged periods of sitting at a desk and working on a computer.
Approximately 50% travel, with the possibility of increased travel during peak periods or as project needs demand.
Must be able to lift to 15 pounds at times.

Skills

GCP
FDA/EMA regulations
ICH guidelines
Clinical trial processes
Written communication
Oral communication
Attention to detail
Organizational skills
Planning skills
Microsoft Office Suite
Clinical trial management systems (CTMS)
Electronic data capture (EDC)

Location

Remote

Work Type

Full-Time
Remote

Experience Level

Senior-level
5–7 years of experience in quality assurance, clinical research, or regulatory compliance
Significant experience in a QA leadership role

Education Level

Bachelor’s degree in Life Sciences, Health Sciences, or a related field
Master’s degree preferred

About the Company

Tekton Research is looking for a remote Quality Assurance Specialist III to join our team.