Quality Assurance Specialist III

This is a fully remote position, open to applicants in United States.

📋 Description

• Perform comprehensive internal audits of clinical research operations, including investigator site documentation, informed consent processes, source records, and data integrity assessments.

• Assess adherence to Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA/EMA regulations, and sponsor stipulations.

• Manage inspection readiness efforts, including conducting mock inspections, and serve as a Quality Assurance (QA) representative during regulatory assessments.

• Identify, assess, and mitigate quality risks across the site network, focusing on critical areas for improvement.

• Create and manage quality enhancement plans targeting systemic risks.

• Lead root cause investigations and formulate complex Corrective and Preventive Action (CAPA) strategies.

• Oversee the implementation of CAPA measures, ensure their effectiveness, and communicate results to senior management.

• Design and execute site-wide quality enhancement initiatives, ensuring they align with industry best practices.

• Develop and revise Standard Operating Procedures (SOPs), work instructions, and quality manuals.

• Provide advanced quality assurance, regulatory compliance, and auditing training to QA team members and clinical personnel.

• Mentor junior and mid-level QA professionals, fostering their development and career progression within the organization.

• Serve as a subject matter expert on regulatory requirements, offering guidance to clinical operations, regulatory affairs, and other relevant parties.

• Collaborate with both internal and external stakeholders to resolve quality-related issues and uphold trial integrity.

• Prepare detailed audit reports and executive summaries for leadership review.

• Analyze quality metrics to identify patterns, improvement opportunities, and areas of excellence.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Health Sciences, or a related discipline (Master’s degree is preferred).

• 5–7 years of experience in quality assurance, clinical research, or regulatory compliance, with considerable experience in a QA leadership capacity.

• Experience in a multi-site clinical research organization or network.

• Extensive knowledge of GCP, FDA/EMA regulations, ICH guidelines, and clinical trial procedures.

• Exceptional written and verbal communication skills, with a keen attention to detail, strong organizational abilities, and planning expertise.

• Capability to maintain high-quality work while managing and prioritizing multiple deadlines.

• Proficient in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint).

• Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), or similar technologies.

• Proven track record of conducting audits and generating comprehensive audit reports.

• Demonstrated experience in leading audits and overseeing regulatory inspections.

🏝️ Benefits

• Must be able to lift up to 15 pounds occasionally.

• Approximately 50% travel required, with potential for increased travel during peak times or as dictated by project needs.

• Extended periods of sitting at a desk and working on a computer.