Manager, Clinical Quality Assurance

Job description

The Manager position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports the department initiatives by leading CQA projects and assists with management of department resources and deliverables. This position must be able to quickly identify critical and high-risk business and compliance issues and report immediately to CQA management and assist/lead investigations and/or corrections of such issues. This position reports to the Director of Clinical Quality Assurance and will be onsite in a hybrid compacity at our Waltham, MA office. - Schedule, conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to: - Audits of clinical vendors, clinical sites and clinical documents that will be submitted to regulatory authorities - Audits of clinical drug safety activities internally and externally/ vendo...