9605 Medical Center Drive Rockville, MD 20850 US
• Develop, monitor and maintain policies and procedures to ensure that all activities related to manufacturing and testing for IND product comply with phase appropriate cGMP regulations and client’ s quality requirements.
• Establish the process for disposition and release of Drug Product for clinical use, including but now limited to timely management of batch record review, resolution of deviations, review and approval of in-process and lot release testing records, issuance Certificates of Analysis.
• Perform a product safety risk assessment, including but not limited to sterility assurance, Chain of Identity, cross contamination prevention, as well as manufacturing consistence.
• Manage suppliers and contractors to ensure contractual obligations and quality requirements are met.
• Lead and resolve complex quality issues and works closely with other functions to resolve significant compliance trends and issues.
• Provide quality leadership and direction for regulatory, internal and supplier/contractors/clinical sites audits and ensure appropriate and timely response, corrective and preventive action, and completion.
• Support and maintain the quality management system, including deviation handling, change control, CAPA, training, product complaint and recall using a phase appropriate and risk-based approach
• Streamline the quality operations, including but not limited to material management, supplier oversight, document control, facility and equipment oversight
• Improve the procedures and operation of Data Integrity of client to Ensure that all activities related to manufacturing processes for IND product comply with cGMP regulations.
• Perform other duties as required
*Previous experience in Cell/Gene Therapy preferred.