QualityControlManager-CellTherapies

**Job Description** The Manager, Quality Control is a key position that provides oversight of a variety of analytical functions that occur in the QC department supporting testing, and reporting of in-process, release, and stability samples. This role also ensures activities occur in an efficient and cGMP compliant manner. The role will have formal people management responsibilities **Key Duties and Responsibilities:** * Manages various laboratory program(s)/processes within the department (assay readiness, training, sample management, data review and reporting) and serves as QC representation at triage and QC of contact for Quality Events. * Coordinates and facilities laboratory activities to meet commitments on-time * Ensure lab personnel have appropriate training. * Assist in troubleshooting of analytical methods and/or equipment as required * Authors, review, and/or approves data, SOPs, * Assist in monitor, tracking and publishing lab metrics * Ensure all laboratory records adhere to cGMP/GDP expectations * Leads sub-teams working towards the goal of continuous improvement * May be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence * Provide guidance to reports when issues arise. Coach and develop reports. * Serves as T1D Cell QC presentative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs **Knowledge and Skills:** * Strong knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections * Strong knowledge of analytical methodologies such as flow cytometry, cell-based assays, qPCR, ELISA, BACT, endotoxin and applying/interpretation of GMP requirements * Effective communication skills, both verbal and written * Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail **Education and Experience:** * Bachelor's Degree