Job Description
<b>Job Description Summary</b>Location: East Hanover, NJ, United States <br>Position is onsite <br>LI#onsite Join Our Vision: At Novartis, we are on a transformative journey in cell and gene therapy, pushing the boundaries of medical innovation. We are currently seeking a dynamic and visionary Sr. Manager to spearhead our Cell and Gene Therapy Analytical Operations Equipment and LIMS group. This pivotal role is not just about leading a team; it's about shaping the future of cell and gene therapy.As the Sr. Manager, Equipment & LIMS you'll be at the forefront of our mission, guiding a talented group of Quality Control associates dedicated to enhancing the digital landscape supporting QC laboratories for Novartis' Cell and Gene clinical products. Reporting to the Head of Cell and Gene Therapy Analytical Operations, you will serve as a vital link among Analytical Development, Pilot Plant manufacturing, Quality Assurance, Instrument Validation and Technical Operations.<br> <b>Job Description</b><b>Key Responsibilities:</b><ul><li>Lead and manage a team of analysts to work closely with the Global GDLIMS team, ensuring <span>the implementation of new systems and improvements of existing systems, including system configuration specification, system administration SOP and executing test scripts following cGxP</span> for Novartis Cell and Gene products in the clinical stages.</li><li><span>Shape and deliver the long-term strategic vision for the Quality Control Digital roadmap</span> by coordinate activities and priorities to meet the required business timelines. Serve as the primary point of contact for communication with management.</li><li><span>Oversee equipment qualifications and validation protocols, risk management tools, gap analysis, CAPA and validation <span>exceptions/deviations</span> for Computer and IT systems. Support initial and routine system risk assessment and testing activities</span>.</li><li>Organize, plan, and support team members with QC equipment or LIMS technical questions and problems, to ensure group efficiency and accountability. Mentor and coach team members to facilitate career growth.</li><li>Ensure that all activities, including training and equipment management, follow current Good Manufacturing Practices, and Health, Safety, and Environmental policies per the global and local Novartis standards.</li><li>Manage change controls, deviations, and CAPA implementation related to QC instrument or GDLIMS.</li><li>Support laboratory inspections and audits, including follow-up actions.</li><li>Plan and manage resources and budget, including capital expenditure (CapEx).</li></ul><b>Requirements:</b><ul><li>BS with a minimum of 6 years of industry experience in biotech or pharmaceutical companies, including at least 2 years of direct people management experience in QC digitalization projects.</li><li><span>Excellent understanding of cGXP requirements and good documentation practices related to systems, equipment and instrumentation within the pharmaceutical industry</span></li><li><span>Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance</span></li><li>Strong communication, writing and presentation skills.</li></ul><b>Desirable Requirements:</b><ul><li>Experience in resource and budget management.</li></ul><b><span>Why Novartis: </span></b>Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? <span><span><span>https://www.novartis.com/about/strategy/people-and-culture</span></span></span><b><span>Benefits and Rewards: </span></b>Read our handbook to learn about all the ways we'll help you thrive personally and professionally: <span><span><span>https://www.novartis.com/careers/benefits-rewards