Manager, Quality Operations - Chemical, External Manufacturing QA -MERCK- USA - PA - West Point

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Join us and experience our culture first-hand – one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Possesses unique combination of analytical/scientific skills as well as excellent managerial skills in order to effectively manage and control all activities necessary to support a Quality Operations program governing external manufacturers of API and API intermediates, in conjunction with and under the direction of the Quality Operations director. Receives guidance on policy issues and direction with regards to operations.

1. Assures that the Quality Operations department operates within established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, EPA, etc.), both domestic and foreign.
2. Assures the development and maintenance of a Quality Agreement with the external manufacturers. Provides input into the development of contractual agreements with the external manufacturers.
3. Executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the external manufacturer.

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