Director of Quality Assurance and Compliance
il y a 4 jours
Biorasi is a leading clinical research organization that values excellence in quality and compliance. We are seeking a highly skilled and experienced Quality Assurance and Compliance expert to join our team.
Key Responsibilities:
- Develop and implement GCP Quality Systems and SOPs
- Provide QA oversight and auditing of eTMFs
- Design and implement a risk-based clinical Quality Assurance management system in partnership with Clinical Operations, Regulatory, and Pharmacovigilance teams
- Identify QA and compliance related issues and implement solutions to ensure timelines are maintained
- Establish metrics and report the state of GCP Quality and compliance of clinical trials to senior management
- Ensure Biorasi quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines
- Oversee the planning and conduct of internal, investigator, and vendor Quality Assurance audits
- Manage the administration of Quality Assurance files and the control of central files
Requirements:
- Master's degree in biomedical sciences or related scientific discipline
- ~10+ years in drug development or clinical research within the pharmaceutical industry or CRO with at least three years in quality assurance, quality management, or clinical safety related area of responsibility
- Proficient with Microsoft Office tools
About Biorasi:
Biorasi is an award-winning, customer-focused, full-service clinical research organization that capitalizes on your strengths while encouraging work-life balance. We are committed to excellence in quality and compliance, and we are seeking a highly skilled and experienced Quality Assurance and Compliance expert to join our team.
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