
Quality Assurance Specialist
Há 14 horas
We are seeking a seasoned quality professional to lead our Quality and Compliance team. This role reports directly to the Director of Quality.
Key Responsibilities- Lead, mentor, and grow a diverse QA team of Clinical Quality Associates
- Identify and implement clinical quality improvement initiatives
- Develop and implement SOPs, templates, and policies related to clinical quality management
- Provide guidance and support on internal SOPs and applicable regulations (e.g., ICH-GCP, US CFR)
- Oversee quality assurance reviews of clinical trial documentation
- Perform risk identification, assessment, and mitigation activities
- Manage non-compliance and clinical quality issues
- Ensure trials are inspection ready at all times
- Host and participate in client audits and regulatory inspections
- 2+ years of experience in managing teams
- 10+ years' experience in clinical research, including 4+ years in quality management
- Proficient in risk-based quality management (RBQM) and relevant ICH-GCP, US CFR, and HIPAA regulations
- Strong understanding of Quality Management Systems and CAPA process
- Ability to work with remote-based teams and excel in fast-paced environments
We reinvent decentralized clinical trials to help patients access clinical research remotely. Our software platform enables data collection and patient engagement across various settings.
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