Quality ICM Issue Lead in Brazil, Indiana at Jobgether
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Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Quality ICM Issue Lead in Brazil.
This role sits within a global clinical research environment focused on ensuring the highest standards of quality, compliance, and patient safety across clinical trial processes. The Quality ICM Issue Lead plays a key role in managing and overseeing quality event investigations from triage through resolution, ensuring adherence to regulatory requirements and internal SOPs. You will be responsible for assessing quality issues, determining escalation needs, and driving thorough root cause analyses. The position involves close collaboration with cross-functional stakeholders, including study teams, subject matter experts, and quality professionals. It is a highly analytical and process-driven role with strong exposure to global quality systems and regulatory expectations. You will also contribute to continuous improvement initiatives that enhance case management efficiency and effectiveness.
- Review, classify, and triage quality issues to determine whether they meet Quality Event (QE) thresholds, ensuring accurate categorization and timely handling within an electronic Quality Management System (eQMS).
- Lead and manage end-to-end QE investigations, including root cause analysis, gap analysis, documentation review, and coordination with relevant stakeholders and SMEs.
- Identify and escalate critical quality events to senior management and regulatory stakeholders when required, ensuring timely and accurate notifications.
- Monitor CAPA plans, track implementation, and evaluate effectiveness of corrective and preventive actions across audits, inspections, and quality events.
- Contribute to process optimization, development of guidance materials, and support digital enhancements in collaboration with technology and quality teams.
- Track risk mitigation actions and provide insights on trends and potential business impacts to support continuous improvement.
- 6–7+ years of relevant experience (or equivalent), with a Bachelor’s degree; alternatively 6+ years with a Master’s degree in a related field.
- Minimum 5 years of experience in pharmaceuticals, clinical research, or GxP/GCP quality environments, including regulatory or audit exposure.
- Strong knowledge of clinical trial processes, GCP requirements, SOPs, and global regulatory standards.
- Experience in data management, process oversight, and quality systems, ideally within a regulated environment.
- Proven ability in root cause analysis, problem-solving, and continuous improvement methodologies (Lean Six Sigma is a plus).
- Strong project management, organizational, and communication skills with the ability to work cross-functionally in a global setting.
- Regulatory inspection experience and familiarity with quality event lifecycle management is highly desirable.
- Competitive base salary with performance-related incentives
- Comprehensive health coverage (medical, dental, and vision, depending on location)
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance and wellbeing programs
- Learning and development opportunities with structured career growth pathways
- Flexible work arrangements, including remote work options where applicable.