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Director Clinical Quality Assurance
3 weeks ago
This role involves execution and performance of Lantheus CQA quality system elements including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents. You will interface with internal and external customers to assess and support compliance with ICH-GCP, cGLP, applicable regulations, and global quality standards.
**Key Responsibilities/Essential Functions:**
- Serve as the CQA lead for assigned trials and assigned compliance areas ensuring timely communication of quality risk and compliance related to GCP/cGLP.
- Development and execution of a risk-based clinical quality audit plan for assigned programs.
- Audit internal processes, clinical investigator sites, and vendors to assess compliance with applicable regulations/guidelines and evaluate accuracy and quality of scientific data as needed.
- Analyze and trend audit observations, gaps, and systematic issues to support continuous improvement within pre-clinical/clinical development programs, vendors, and cross-functional groups.
