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The Manager, Quality Control Operation will be responsible for ensuring that day-to day QC laboratory operation is performed in a manner that is compliant with GMP/FDA regulations, AAA and Novartis standard operating procedures.
Your responsibilities include, but are not limited to:
* Lead and Oversee day-to-day operation of QC laboratory * Provide leadership, direction, and support to the people within the Quality Control * Keep up with industry trends and best practices. Drive spirit of continuous improvement to ensure Inspection readiness state. * Manage QC KPIs (timeliness, training, testing cycle time, periodic review, etc.) * Oversee stability testing program at Millburn facility * Collaborate with Global organization to resolve any analytical testing problems, recommend appropriate changes, if required. * Ensure QC events are categorized and escalated timely * Conduct or delegate laboratory investigations, including OOS/OOT/OOEs, and deviations * Writing, review and approval of documents needed for laboratory operation, such as SOP's, methods, specifications, change control requests, etc. * Drive all technical aspects related to quality control testing readiness including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing * Act as Subject Matter Expert in his or her area of expertise: primary contact for troubleshooting, deviation/OOS investigations, assess product and environmental data and performs trending, and QC documentation management * Select, train, supervise laboratory personnel in the performance of the testing procedures required to meet regulatory and scientific standards for pharmaceutical products. Staff performance management and development * Act as designee "deputy" and make key decisions regarding quality control processes in the absence of the QC Head * Ensure the implementation, ongoing monitoring and reporting of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) that drive continual improvement QC organization. * Ensure that QC testing is properly conducted and documented for all performed activities, with emphasis on Data Integrity. Evaluate and approve QC records as required. * Facilitates a culture of "speaking up" and ensuring all cGMP compliance activities are followed * Support regulatory inspections and audits * Participate in proving input to the preparation of the QC budget of the Quality Unit * Ensure health & safety procedures are followed