Technical Manager, Quality Assurance - (Chicago, IL)

ESSENTIAL DUTIES AND RESPONSIBILITIES: The successful applicant should be able to perform the following QA responsibilities and activities. This includes but is not limited to: Perform supplier risk assessments in support of QA Vendor Qualification program Manage QA’s Vendor Qualification program, track progress and provide updates to project teams, when necessary Develop QA’s annual auditing plan and track progress Perform QA GMP vendor audits and write audit reports with findings, when necessary Review and approve GMP manufacturing and Validation documents, when necessary Assist with the development and management of Quality Systems (Deviations, CAPAs, Change Control, etc.) Manage, review and approve Change Controls (CC) and CC packages for closure Manage, investigate, review and approve Deviation reports and CAPAs Assist with system administration of Veeva QualityDocs