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The clinical quality assurance AD/Director will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency regulations and standards, GCP, industry guidelines, and Apnimed policies and procedures for the conduct of clinical studies.
The position will utilize audit and inspection intelligence, SOP development, training and risk mitigation plans to assure adherence to GCP/GVP requirements in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients. The position is accountable for the execution of Quality Assurance (QA) audit and inspection activities for assigned sponsor, investigator sites, vendors and IRB & Ethic committees in preparation for BIMO inspections. This role is responsible for GxP compliance and to ensure the adherence to Apnimed Standard Operating Procedures, Policies, and all applicable worldwide regulations and guidelines (e.g., US FDA, EU Directives, ICH).
KEY RESPONSIBILITES:
QUALIFICATIONS:
WHAT APNIMED OFFERS:
LOCATION AND OTHER INFORMATION:
Full Time
$141k-169k (estimate)
06/26/2024
07/13/2024
apnimed.com
Cambridge, VT
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