Senior Principal Quality Site Manager, Drug Product Contract Manufacturing
Genentech, Inc. - Greenville, NC

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Passionate About Science
We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases.

The following opportunity exists in our Greenville, North Carolina facility:

Senior Principal Quality Site Manager, Drug Product Contract Manufacturing

Responsibilities:
The Senior Principal Site Manager will manage the Quality oversight related to sterile drug products manufactured at a Contract Manufacturing Organization (CMO) located in Greenville, North Carolina. This person will be the Quality “Person-in-the-Plant” and will be a key member of the CMO governance team to support right to operate and quality supply of three critical biologic products, including a product launch.

The Manager will influence and drive Right to Operate and continuous improvement to achieve compliant and reliable supply of Roche products, including a successful product launch. He/she will establish and monitor CMO Quality and Compliance goals and metrics to drive continuous improvements; proactively drive quality and compliance excellence. He/she will recommend, implement, and drive strategic objectives and goals of the CMO relationship. The candidate will manage the release of product, including batch record review, investigations, change controls. He/she will observe end-to end production activities that include 3 filling lines, thawing, compounding, visual inspection, and bulk packaging operations. He/she will partner with the CMO to ensure proper aseptic control during Roche operations. The candidate will support validation activities, product complaint investigations, creation of Annual Product Reviews, and other quality functions as required. The Manager will develop/maintain quality risk management plans and risk logs; utilize risk management tools to identify and mitigate CMO quality and compliance risks. He/she will manage and participate in regulatory inspections and Genentech compliance audits at the CMO to secure successful inspection outcomes. The candidate will serve as the Quality representative on cross-functional and multi-site teams and gain internal alignment on cross-functional activities and projects.

About this company
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Genentech, Inc. (Genentech) is a biotechnology company that discovers, develops, manufactures and commercializes pharmaceutical products to...