Ensure Compliance and Quality Across Clinical Operations
As a Quality Assurance Specialist, you will play a central role in maintaining regulatory compliance with FDA, ICH, and GCP guidelines. Your work will focus on auditing processes, evaluating quality systems, and identifying potential compliance risks before they arise.
Key Responsibilities
- Conduct internal and system-level audits to verify adherence to regulatory standards
- Monitor and assess the effectiveness of quality management systems
- Identify, investigate, and resolve compliance deviations efficiently
- Oversee the control and accuracy of regulated documents and training records
- Support preparation for regulatory inspections and internal reviews
- Lead and track corrective and preventive actions (CAPA) across departments
- Collaborate with cross-functional teams to promote quality-first practices
- Drive initiatives that enhance operational performance and compliance maturity
- Analyze quality metrics to inform risk-based decision-making
- Provide ongoing guidance to strengthen quality oversight organization-wide
Qualifications
- Demonstrated experience in regulated clinical research environments
- Familiarity with FDA, ICH, and GCP regulatory requirements
- Proven ability to execute audits and evaluate compliance findings
- Track record of resolving compliance issues through structured methodologies
- Experience managing controlled documentation and training systems
- Background supporting inspection readiness and post-inspection follow-up
- Strong collaboration skills with the ability to influence across teams
- Experience leading CAPA processes and continuous improvement projects
Why This Work Matters
Your contributions will support the delivery of reliable, high-quality clinical research that advances treatments for patients and families. You'll be part of a purpose-driven culture focused on integrity, quality, and real-world impact—where your expertise helps uphold the highest standards in patient care and regulatory compliance.
