Principal Auditor Quality Assurance in Brazil, Indiana at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Auditor Quality Assurance in Brazil.

This role sits at the core of global clinical quality and compliance operations, ensuring that clinical trial processes meet the highest regulatory and scientific standards. You will lead complex quality assurance audits and investigations, driving the identification, assessment, and resolution of quality events across clinical and operational systems. Acting as a key expert in Good Clinical Practice (GCP) and GxP environments, you will collaborate with cross-functional teams to strengthen compliance, improve processes, and mitigate risks. The position combines strategic oversight with hands-on investigation work, including root cause analysis and corrective action planning. You will also play a critical role in monitoring quality metrics, escalating significant issues, and supporting regulatory readiness. This is a high-impact opportunity within a global, science-driven environment where quality directly influences patient safety and clinical outcomes.

• Lead and execute comprehensive quality audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and internal quality frameworks.
• Manage quality event case handling, including triage, investigation, escalation, and coordination through the full lifecycle of issue resolution.
• Conduct root cause analysis, gap assessments, and due diligence activities to identify underlying issues and drive effective corrective and preventive actions (CAPA).
• Develop and implement audit plans and quality assurance strategies to evaluate the effectiveness of quality management systems.
• Collaborate with cross-functional teams to identify process gaps and recommend improvements in compliance, operational efficiency, and risk mitigation.
• Monitor quality performance indicators and ensure timely escalation of critical issues to senior management and regulatory stakeholders when required.
• Support continuous improvement initiatives, strengthening quality systems, audit readiness, and compliance culture across the organization.

• Bachelor’s degree in a scientific, healthcare, or related field; MBA or Master’s degree is a plus.
• 6–7+ years of experience in quality assurance, compliance, or clinical research environments.
• Strong experience in pharmaceutical or clinical trial operations, including GCP, GxP, and regulatory frameworks.
• Proven experience in quality audits, regulatory inspections, or quality event management.
• Strong knowledge of clinical trial processes, SOPs, and applicable regulatory requirements.
• Experience in root cause analysis, CAPA development, and process improvement methodologies.
• Strong analytical, project management, and problem-solving skills with ability to manage multiple priorities.
• Excellent communication skills for engaging with technical and non-technical stakeholders.
• Experience with continuous improvement methodologies (e.g., Lean Six Sigma) is highly desirable.

• Competitive compensation aligned with experience and market standards.
• Remote work flexibility with global collaboration opportunities.
• Comprehensive health insurance options for employees and families.
• Retirement and financial planning support programs.
• Life insurance coverage.
• Employee assistance program offering 24/7 global well-being support.
• Flexible benefits package depending on country, including wellness, travel, and lifestyle perks.
• Strong emphasis on work-life balance and inclusive work culture.
• Opportunity to work in a global organization shaping clinical research and patient outcomes.