Description
Position: Quality Assurance Systems Manager / CompliancePosition Reports To: Sr. Director Quality Systems and Compliance
Responsibilities:
- Responsible for managing the daily activities related to the Vendor Audit Program for contract manufacturer/ laboratory,
- Manage and assure timely CAPA program
- Participate with handling Product Quality Complaints; Change control, label control
- Participate/lead as a key member of the regulatory agency inspection team
- Maintain current Quality Related documents via SharePoint file-access
- Champion upgrades of the Vendor Mgmt Program to support a Global Business
Experience:
- 8+ years experience in Quality Assurance with a focus on performing audits in a Global environment; US, Canada and European markets
- Author SOP's related to all supporting functional areas
- Database exposure and Quality Management Systems experience
- Experience in the pharmaceutical, biotech, supply chain (distribution); computer audit experience a plus
- Livelink, TrackWise, ComplianceWire a plus
To find out more about Real please visit www.realstaffing.com