Director QA, GMP External Operations Cell and Genetic Therapies

Job Description

General/Position Summary
The Director, Quality Assurance GMP Operations is responsible for the applicable Cell & Gene CDMO and is responsible for the end to end quality oversight of all product and activities at the CDMO. Responsibilities include day-to day operational quality oversight including assuring progression of batch record operations, resolution and on time disposition of product, quality continuous improvements, changes associated with the process and associated implementation, trends, and overall quality performance of the CDMOs.

The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk mitigation, execution of operational activities and participation in governance committees. A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders to drive compliance and continuous improvement activities. ...