
Quality Assurance Manager
2 weeks ago
A leading biotech company in advanced clinical development stages is seeking a
Clinical QA Manager
for a key role with full responsibility for the Quality Management System (QMS) and all QA activities related to clinical trials in compliance with GCP standards.
Responsibilities
- Manage and maintain all QMS documentation and record
- Develop and update SOPs in accordance with evolving regulation
- Provide ongoing updates to the clinical team on regulatory changes and their impact
- Build and execute the annual audit plan
- Report directly to senior management on the status of the clinical quality system
Requirements
- 5+ years of experience in QA within clinical trial
- Proven and in-depth knowledge of GCP / GCLP standard
- Hands-on experience with electronic quality systems (eQMS, eLMS)
- Strong organizational skills and attention to detail, with the ability to manage multiple tasks simultaneously
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