Specialist, Quality Assurance
New
BrazilFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Professional fluency in Portuguese and English is required; Spanish is considered an advantage.
- Experience
- 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.
- Required Skills
- GCPQuality Assurance
Requirements
- Bachelor's degree or equivalent qualification.
- Minimum of 2 years of experience in Quality Assurance.
- 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.
- Familiarity with 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.
- Excellent written and verbal communication skills.
- 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.
- Professional fluency in Portuguese and English.
- Willingness to travel occasionally (less than 10%) for planned business needs.
Responsibilities
- 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.
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