General Scope & Summary

The role of a Quality Assurance Executive in the clinical research industry is crucial to ensuring compliance with regulatory requirements, industry standards, and internal quality systems. They are responsible for designing and implementing quality assurance programs, conducting audits and inspections, identifying areas for improvement, and ensuring adherence to Good Clinical Practice (GCP) guidelines. By overseeing quality management processes and providing guidance to the team, they play a vital role in maintaining the integrity, accuracy, and reliability of clinical trial data and the overall success of research studies.

Roles and Responsibilities

• Developing and implementing quality assurance policies and procedures to ensure compliance with regulatory requirements and industry standards.
• Conducting internal and external audits and inspections to assess compliance with Good Clinical Practice (GCP) guidelines and quality management systems.
• Reviewing and approving study documents, protocols, and Standard Operating Procedures (SOPs) to ensure they meet regulatory and quality standards.
• Providing guidance and training to project teams and staff on quality assurance practices and processes.
• Investigating and resolving quality-related issues, deviations, and non-compliance, and implementing corrective and preventive actions to improve overall quality and ensure data integrity.

Qualifications

• Bachelor’s or Master’s degree in a relevant scientific field or a related discipline
• Certification in Good Clinical Practice (GCP) and/or Quality Assurance (QA)
• Strong knowledge of regulatory requirements and guidelines (e.g., ICH-GCP, FDA regulations)
• Excellent understanding of quality management systems and quality assurance principles
• Previous experience in clinical research or a related field, with a focus on quality assurance and compliance