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Manager, Quality Control Operations


Security Operations


Millburn, New Jersey, United States

236 million lives were touched by Novartis medicines in 2022, 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><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 Quality Control Operations Manager 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. Due to the nature of the process (radioactive) this role requires basic proficiency, ownership of the quality control techniques, and understanding of radiation safety standards.<br><br>Main responsibilities:<br><br>• Oversees day-to-day operation of Quality Control laboratory and develop the skills of their team for career growth, keeps up with industry trends and best practices and drives spirit of continuous improvement to ensure Inspection readiness state.<br>• Manages Quality Control Key Performance indicators (KPIs) (timeliness, training, testing cycle time, periodic review, etc.), oversees stability testing program at Millburn facility and collaborates with Global organization to resolve any analytical testing problems, recommend appropriate changes, if required.<br>• Ensures quality control events are categorized and escalated timely and conducts or delegate laboratory investigations, including OOS/OOT/OOEs and deviations. Ownership and/or oversights of laboratory based corrective and preventive actions (CAPA) implementation.<br>• Writes, reviews, and approves documents needed for laboratory operation, such as Standard Operating Procedures (SOP’s), methods, specifications, change control requests, method and equipment validation activities, etc.<br>• Supports their team for all technical aspects related to quality control testing readiness, including Quality Control (QC) reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management, and QC testing.<br>• Acts as Subject Matter Expert in his or her area of expertise: primary contact for troubleshooting, deviation/OOS investigations, assesses product and environmental data and performs trending, and QC documentation management.<br>• Selects, trains, supports laboratory personnel in the performance of the testing procedures required to meet regulatory and scientific standards for pharmaceutical products. <br>• Acts as designee and make key decisions regarding quality control processes in the absence of the QC Head, facilitates a culture of “speaking up”, ensures all compliance activities are followed and supports regulatory inspections and audits.<br><br>NOTE: Wed-Sat PM shift 12 PM-10 PM<br>10% differential<br><br>The pay range for this position at commencement of employment is expected to be between $102,400 and $153,600 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.<br><br>[#video#{#400,300#}#/video#]