About the role
A mid-sized biotechnology research company in Cary is hiring for this role. You will provide clinical quality oversight across studies and own the quality events that come out of them. You will also build the standards and tools that strengthen the quality management system (QMS).
What you'll do
- Review clinical documentation and provide quality oversight across studies
- Oversee GCP compliance and keep studies ready for inspection
- Audit CROs and other vendors
- Own quality events, deviations, root cause analyses and CAPAs
- Develop standards, tools, training and metrics to improve the QMS
What you bring
- Experience in clinical quality assurance at a senior level
- Working knowledge of GCP requirements
- Experience auditing CROs and vendors
- Experience leading root cause analyses and CAPAs
- Experience with inspection readiness and QMS improvement
Details
- Location: Cary, United States
- Type: Contract
Apply below and a Traverse recruiter will be in touch.