Dir. QA Dev & Val

Novartis Vaccines & Diagnostics, Inc.

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Location: Emeryville, CA Posted Date: 4/25/2013 Position Type: Full time Job Code: 3641814HHL Salary: Competitive Required Education: Doctorate/PhD Areas of Expertise Desired: Allied Health

Description

This position has overall responsibility for QA oversight to projects/programs requiring design control, technical and label review, and QA oversight of appropriate validation strategies for development and GMP processes that are in accordance with company policies, compliance with Novartis Quality Manual and per the guidelines and requirements of the Code of Federal regulations. In addition, provide key quality/compliance input to technical decisions involving process or analytic changes. This position will also serve on design and development project(s) as a QA technical resource and will interact with Process and Analytic Development Scientists to ensure that quality compliance requirements are understood while executing changes, investigations and product characterization. Consult with Technology Development group on scientific processes and process improvement, and new product development. This position will manage a team of Managers and Specialists who are responsible for creating and executing specific quality plans for design and development projects, guiding and influencing new product teams through design and into validation and verification, and interfacing to assure compliance and robust product vs. customer/product requirements. Additionally providing oversight of Validation for GMP manufacturing equipment, facilities, processes and methods. As Required
B.S. or M.S. in Chemistry, Biochemistry or related discipline. Ph.D. preferred. English As Required

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