This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Specialist, Quality Assurance based in Brazil.
This is an exciting opportunity for a quality-focused clinical research professional to help maintain excellence across clinical operations and regulatory compliance. In this role, you will support quality assurance initiatives for both traditional and decentralized clinical trials, ensuring patient safety, data integrity, and adherence to GxP standards. Working closely with cross-functional teams, you will contribute to audit readiness, process improvement, CAPA management, and quality systems development. The position offers broad exposure to quality management activities while encouraging innovation, continuous learning, and the adoption of digital and AI-enabled solutions. This fully remote role is ideal for someone who thrives in a collaborative, fast-paced environment and is passionate about advancing healthcare through high-quality clinical research.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Specialist, Quality Assurance based in Brazil.
This is an exciting opportunity for a quality-focused clinical research professional to help maintain excellence across clinical operations and regulatory compliance. In this role, you will support quality assurance initiatives for both traditional and decentralized clinical trials, ensuring patient safety, data integrity, and adherence to GxP standards. Working closely with cross-functional teams, you will contribute to audit readiness, process improvement, CAPA management, and quality systems development. The position offers broad exposure to quality management activities while encouraging innovation, continuous learning, and the adoption of digital and AI-enabled solutions. This fully remote role is ideal for someone who thrives in a collaborative, fast-paced environment and is passionate about advancing healthcare through high-quality clinical research.
Accountabilities
- Perform quality assurance reviews across clinical research sites to ensure compliance with GCP, SOPs, regulatory requirements, and data integrity standards.
- Review regulatory documentation and study records to verify accuracy, completeness, and ongoing compliance throughout clinical trials.
- Execute internal quality audits, monitor audit findings, prepare reports, and track corrective actions to completion.
- Develop, monitor, and support Corrective and Preventive Action (CAPA) plans in collaboration with research staff and Principal Investigators.
- Coordinate and support sponsor, regulatory, and third-party audits and inspections while promoting continuous inspection readiness.
- Maintain and improve quality management systems, compliance trackers, documentation, and operational quality processes.
- Assist with the creation, review, and maintenance of Standard Operating Procedures (SOPs) and other quality documentation.
- Provide quality guidance and compliance support to cross-functional teams across multiple clinical research programs.
- Deliver training related to quality systems, compliance, and continuous improvement initiatives.
- Support proposal responses, AI quality initiatives, quality management projects, and other GxP and non-GxP quality activities as needed.
- Bachelor's degree or equivalent qualification.
- Minimum of 2 years of experience in Quality Assurance and at least 4 years of experience in clinical research within a compliance, GCP, or quality-related role.
- Strong knowledge of GxP principles, Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and applicable regulatory frameworks, including 21 CFR Part 11 and Part 312.
- Experience conducting or supporting internal and external audits, regulatory inspections, CAPA management, and quality management systems.
- Ability to identify compliance gaps, manage multiple priorities, and work independently in a dynamic regulatory environment.
- Excellent written and verbal communication skills with the ability to deliver training and collaborate effectively across multidisciplinary teams.
- Strong analytical thinking, organizational skills, attention to detail, and problem-solving capabilities.
- Comfortable working with digital platforms, quality systems, and emerging technologies, including AI-supported initiatives.
- Demonstrated ability to drive process improvements while maintaining a collaborative, service-oriented mindset.
- Professional fluency in Portuguese and English is required; Spanish is considered an advantage.
- Willingness to travel occasionally (less than 10%) for planned business needs.
- Fully remote work within Brazil.
- Paid time off (PTO) and company-paid holidays.
- Medical, dental, and vision insurance plans.
- Opportunity to contribute to meaningful healthcare and clinical research initiatives.
- Collaborative, mission-driven work environment with opportunities for professional development and continuous learning.
- Exposure to innovative quality systems, decentralized clinical research, and AI-enabled quality initiatives.