Principal Auditor Quality Assurance
BrazilFull-TimePrincipal
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- 6–7+ years of experience
- Required Skills
- Project ManagementGCPAnalytical SkillsProblem SolvingComplianceQuality AssuranceProcess improvement
Requirements
- 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.
Responsibilities
- 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.
View Full Description & ApplyYou'll be redirected to the employer's site
