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Head, Production Support

Manufacturing and Production

Production Controller

Yearly

No

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 Head, Production Support has responsibility for building and leading a group that is responsible for deviations, CAPAs, continuous improvement projects, internal training, and batch record/SOP authorship.<br><br>Your responsibilities include, but are not limited to:<br><br>● Drives investigations to true root cause, and implementation of corrective and preventive actions.<br>● Authoring/Owning/Ensuring investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging.<br>● Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers.<br>● Review of product support documentation (e.g., batch records, process validation, work orders, production of log books).<br>● Perform/Review appropriate root-cause analysis for events utilizing investigation tool (e.g., 5 whys, Fishbone Diagrams).<br>● Assign proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events.<br>● Utilize appropriate risk management tools for recommendation on disposition of materials.<br>● Present completed investigations for final approval.<br>● Performance of risk assessments.<br>● Meeting facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.<br>● Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of exception events.<br>● Leads site-wide cross-functional initiatives identified by site leadership team as critical to the success of the site.<br>● Key user for the site for new Quality Systems implementation.<br>● Advisor to associates who would like to become a certified investigator.<br><br>Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.