The Senior Manager, Clinical Quality Assurance is responsible for supporting Quality oversight of clinical activities. The Senior Manager, Clinical Quality Assurance performs and manages clinical quality assurance activities and is responsible for ensuring that clinical trials are conducted to the highest GCP and quality standards and clinical processes within the Clinical Group are conducted in accordance with corporate SOPs, guidelines, and regulations. This is a remote-based position located in the United States.
Responsibilities:
- Ensure that all processes contributing to the performance of a clinical trial are conducted properly
- Prepare and manage the Drug Development Quality Management Plan including risk management, SOPs, training, regulatory compliance, and audit readiness
- Evaluate adequacy of quality assurance standards for the Drug Development Group
- Directly interface with Drug Development departments and corporate QA to provide for vendor, site, and internal GCP audits
- Evaluate audit findings and review/approve corrective actions
- Support compilation and preparation of materials for submission to regulatory agencies
- Evaluate quality events, incidents, and queries
- Provide clinical operations expertise in cross-functional meetings and will directly work or manage teams that work closely with overall compliance and quality in accordance with Elevar SOPs, ICH guidelines, and GCP best practices
- Draft clinical quality assurance policies and procedures in accordance with corporate QA policies and standards
- Ensure inspection readiness of all regulated activities
