Manager, Clinical Quality Assurance
About The Position
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.
Requirements
- Compliance with cGCPs
- Identify critical and high-risk business and compliance issues
- Report immediately to CQA management
- Assist/lead investigations and/or corrections of issues
Responsibilities
- Provides oversight for and participates in auditing services in support of Alkermes Clinical Programs.
- Conducts clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs.
- Supports department initiatives by leading CQA projects.
- Assists with management of department resources and deliverables.
- Quickly identifies critical and high-risk business and compliance issues and reports immediately to CQA management.
- Assists/leads investigations and/or corrections of critical and high-risk business and compliance issues.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
