Associate Director, Quality Assurance – Facilities Mgmt.
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About The Position
This role will be responsible for Quality Assurance oversight of Facilities Management activities related to internal GMP operations at both the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA and the Quality Control Laboratories located in Woburn, MA. This role will work closely with the Facilities Management teams at both locations to ensure planned maintenance, unplanned (corrective) maintenance, and calibration activities meet cGMP requirements for the documentation, trending, and escalation of issues. Efforts are focused on ensuring equipment, facilities, and utilities are maintained in a qualified/validated state for Manufacturing and Testing purposes. Core activities include review and approval or maintenance plans, review and approval of unplanned (corrective) maintenance work records, and the development or improvement of maintenance work management processes. This role primarily partners with the Facilities & Engineering teams and closely with Validation, Manufacturing, and Quality Systems. This role will also manage the performance and development of direct reports to support these activities.
