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The Manager Pre-Production Quality reports to the Site Head of Quality. This role will be responsible for Quality oversight of warehouse operations for incoming materials and quality oversight for material selection for products manufactured at the Rockville facility. The responsibilities of this role also include oversight of onboarding new programs and establishment of master batch records and other aspects as part of new product introduction for successful execution of manufacture of batches. This role also supports client and regulatory audits and inspections and will be expected to oversee and execute implementation of continuous improvement initiatives. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new cellular therapy production.