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Manager, Quality Control Operation (342029BR)





Millburn, New Jersey, United States

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. <br>We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!<br>Imagine what you could do here at Novartis!<br><br>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. <br><br>Your responsibilities include, but are not limited to: <br><br>• Lead and Oversee day-to-day operation of QC laboratory<br>• Provide leadership, direction, and support to the people within the Quality Control<br>• Keep up with industry trends and best practices. Drive spirit of continuous improvement to ensure Inspection readiness state. <br>• Manage QC KPIs (timeliness, training, testing cycle time, periodic review, etc.) <br>• Oversee stability testing program at Millburn facility<br>• Collaborate with Global organization to resolve any analytical testing problems, recommend appropriate changes, if required. <br>• Ensure QC events are categorized and escalated timely <br>• Conduct or delegate laboratory investigations, including OOS/OOT/OOEs, and deviations<br>• Writing, review and approval of documents needed for laboratory operation, such as SOP’s, methods, specifications, change control requests, etc.<br>• 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<br>• 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<br>• 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<br>• Act as designee “deputy” and make key decisions regarding quality control processes in the absence of the QC Head<br>• Ensure the implementation, ongoing monitoring and reporting of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) that drive continual improvement QC organization.<br>• 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.<br>• Facilitates a culture of “speaking up” and ensuring all cGMP compliance activities are followed<br>• Support regulatory inspections and audits <br>• Participate in proving input to the preparation of the QC budget of the Quality Unit <br>• Ensure health & safety procedures are followed<br><br> <br>[#video# {#400,300#}#/video#]