Director of Quality for Cell Therapy - (Boston, MA)

Director of Quality AssuranceMy client is focused on cell therapy products, and they actively seek a QA Director. The perfect candidate will take on the following tasks: Establish, develop and manage the quality management system for the firm. Build the quality department infrastructure to assure compliance to company, industry standards and the applicable regulatory qualifications. Interface with external personnel (vendors, partners and regulatory bodies) and internal personnel (management and staff) to drive Quality Assurance tasks and milestones. Handle audit planning (including supplier audits), conduct, findings, responses, and corrective and preventative actions. Perform and direct quality system internal audit activities and drive improvements within the local quality system. Design and implement a phase-appropriate quality management system for a combination product in an organization with both internal and outsourced manufacturing.