Senior Director, Project Quality
New
J
JobgetherClinical Research
Based in the United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- At least 8 years
- Required Skills
- GCPRisk Management
Requirements
- Master’s degree or equivalent qualification.
- At least 8 years of experience in quality and compliance management within a clinical research environment.
- Strong understanding of clinical research activities and processes within hospital, clinic, or research-site settings.
- Expert knowledge of clinical research Quality Management System requirements and quality management practices.
- Comprehensive understanding of clinical research processes and research site conduct.
- Expert-level knowledge of quality issue identification, triage, root cause analysis, CAPA, risk assessment, and impact analysis.
- Expert working knowledge of GCP guidelines, applicable regulations, regulatory documentation, and IRB submission requirements.
- Demonstrated ability to lead cross-functional initiatives, influence stakeholders, and build strong relationships.
- Proven leadership capabilities, including mentoring, training, and developing employees.
- Willingness and ability to travel up to 30%, with occasional evening or weekend work as required.
- Strong proficiency with Microsoft Office 365 and other business technology tools.
Responsibilities
- Build, implement, and manage a company-wide Quality Management System, including controlled documentation.
- Lead required QMS reviews and oversee the research, implementation, and management of an electronic QMS solution.
- Establish and lead the Project Quality team, defining staffing and training needs.
- Guide operational teams through quality issues, root cause analysis, and corrective and preventive actions (CAPA).
- Lead site preparation for sponsor audits and regulatory inspections, including support for response letters.
- Monitor and report quality performance, trends, and risk indicators to senior leadership.
- Monitor site compliance with FDA guidance, SOPs, GxP requirements, and clinical research standards.
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