365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.

This role is responsible in ensuring compliance to GxP standards for Cell and Gene Therapy Products including safety testing, monitoring, and trending for globally distributed products while having an understanding and focus on analytical techniques, aseptic operations, and policies. This role is primarily responsible to ensure compliance to GxP standards for Cellular and Gene Therapy Products, including safety testing, monitoring and trending for Globally distributed products while having an understanding and focus on aseptic operations, techniques and requirements. Ensures that the standards and policies of the Quality Unit are adequately designed and enforced in compliance with the Novartis Quality Manual and cGMP standards while also taking into consideration specific requirements from ex-US countries (i.e. EU, Japan). Proactively drives changes and improvements to QC Analytics and QC Micro while establishing a culture of compliance through implementation of harmonized standards, testing, monitoring and reporting. Lead a group of group heads and associates and represent Quality leadership. Set up organizational structures to improve efficiency and throughput (incl. Automation). Engage in projects to assure GMP beyond compliance and state of the art scientific approach to Cell and Gene Therapy Quality.
This role is also responsible to lead the AS&T strategy for the Platform, including receiving of method from TRD, validate and transfer to other sites (internal & external), support stability program across the CGT Platform, method optimisation and accountability for Global change controls.
Your responsibilities include, but are not limited to:
Direct and assist in functions to drive success within the Quality Control department. Duties include:
• Maintain the Quality Control laboratories in cGMP compliance and continue to challenge the status quo of the laboratory to enhance throughput efficiency, compliance, and testing platforms.
• Lead the AS&T strategy for the Platform, including receiving of method from TRD, validate and transfer to other sites (internal & external), support stability program across the CGT Platform, method optimisation & technology procurement for next generation QC assays and accountability for Global change controls.
• Proactively drives changes and improvements to AS&T and Quality Control while establishing a culture of compliance through implementation of harmonized standards, testing, monitoring, and reporting for the Morris Plains site and CGT Platform.
• Ensure timely closure of investigations and implementation of appropriate CAPA.
• Accountable to ensure testing follows appropriate protocols, test methods, and compendia (United States Pharmacopoeia (USP), American Chemical Society (ACS)).
• Accountable for raw material testing, in-process and final product analytical testing such as flow cytometry, ELISA, cell count, cell viability, sterility, endotoxin, and qPCR and microbiology testing.
• Leads the development, revision, application, maintenance, validation, and review of quality standards, documents, and methods for processing and/or ensuring quality in intermediates or finished products.
• Assure that all test methods and specifications compliant with current USP/NF.
• Knowledge and familiarity of SAP systems, including Quality Module (QM).
• Knowledge and familiarity of LIMS systems (Labware LIMS) and Trackwise
• Knowledge and familiarity of Quality Documentation systems
• Assure qualification status of critical reagents
• Drive 5S and lean projects
• Ensure all samples and reagents have been prepared, tested, or inspected according to specifications and current testing.
• Govern method revision and transfers
• Governs successful completion of method validation protocols and reports.
• Leads optimization for CGT Platform of test procedures to improve efficiency whenever possible.
• Provides feedback (formal and informal) to team members on routine basis
• Execute performance appraisals for direct reports
• Responsible that training is performed and documented for laboratory personnel in order that all analysts are qualified to perform the assays under CGMPs.
• Ensure the laboratory is operating while following industry requirements, Novartis cGMP standards, and Global requirements
• Ensures that laboratory scheduling, logistics, and flow of activities for testing and review are set and followed.
• Prepare and participate in Health Authority inspections and internal audits and support inspections at other sites CGT sites (internal and external).
• Participate in the preparation and consolidation of the budget of the Quality Unit
• Ensure health & safety procedures are followed within the Laboratory
• Ensure programs are in place for trending which includes determination of alert and action limits and systems in place to act accordingly
• Ensures maintenance of GMP and GLP systems and environment.