lottebiologicsusallc · Syracuse, NY
We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World . A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science , Embracing Diversity , Fostering Talent , and Connecting Lives . Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide. Position Summary 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 Leads and provides management oversight to the QA Program Teams. Represent Quality Assurance on New Product Introduction teams by directly interfacing with client, serving as decision maker and Quality SME Accountable for ensuring deviation investigations are based on sound scientific rational and appropriate actions are taken to prevent recurrence. Ensures that all QA Program Team personnel have adequate training, education and experience to perform their GMP related…
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