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Sr. Manager, QA Program Lead
Lotte · Syracuse, NY · Posted 8 days ago
Serve as the main Quality decision-maker and SME for external clients while leading QA Program Teams through new product introductions and technical transfers at a cGMP manufacturing site.
The Sr. Manager QA Program Lead is responsible for providing Quality Assurance technical expertise and guidance to internal and external customers during new product introduction and technical transfer activities as well as for established existing customers. The Sr. Manager will serve as the main Quality contact for clients and is expected to interact directly and often with clients, especially with client Quality representatives. The Sr. Manager will be responsible for negotiating with clients to generate the Quality Agreement and ensuring compliance with its requirements, including providing client notifications as required.
In addition, the Sr. Manager will oversee client-specific change control activities, including record and action approval as needed. This role will also provide oversight and approval of site deviations, as well as on-the-floor Quality support as needed to ensure compliant and efficient operations. The Sr. Manager is also expected to support additional site needs as required to ensure overall Quality and operational success.
Duties & Responsibilities
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There are 9 open roles at Lotte right now. This role centers on Cgmp, Quality Assurance, Quality Agreements, and Change Control.
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