Reviewing and approving quality records/documentation from third parties, including but not limited to product and process change controls (e.g., master batch records, API, raw material, product specifications, analytical methods), stability and validation protocols/reports, quality incidents and investigation reports, quality agreements and technical transfer documentation. The Quality Assurance Manager, External Manufacturing will be primarily responsible for supporting GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements.