Senior Director, Project Quality
New
F
Flourish ResearchClinical Research
United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- Minimum 8 years’ experience
- Required Skills
- GCP
Requirements
- Master’s degree or equivalent education.
- Minimum 8 years of experience in quality and compliance management within a clinical research environment.
- Expert working knowledge of clinical research quality management system requirements.
- Comprehensive knowledge of clinical research processes and research site conduct.
- Expert-level understanding of the quality management process, including issue identification, triage, RCA, and CAPA.
- Expert working knowledge of GCP guidelines, regulatory regulations, and IRB submission requirements.
- Expert knowledge of data compliance and best practices for clinical research sites.
- Excellent leadership skills, including mentoring and training staff.
- Strong problem-solving, risk assessment, and impact analysis abilities.
- Excellent oral and written communication skills.
- Proficiency with Microsoft Office 365 products.
- Ability to travel up to 30%.
Responsibilities
- Build, implement, and manage a companywide QMS and create supporting controlled documents.
- Research, implement, and manage an eQMS solution across all sites.
- Create and lead a Project Quality team, including defining needs, training, and processes.
- Monitor project quality compliance, including quality management plans, risk assessments, and quality evaluations.
- Provide expert guidance on SOP harmonization and ensure compliance with regulatory standards.
- Report on quality metrics, trends, and organizational health to senior leadership.
- Lead and prepare sites for sponsor audits and regulatory inspections, including managing responses to IRBs and the FDA.
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