Quality Control Manager

Job Description:Insight Global is seeking a Quality Control Manager for a cutting-edge clinical laboratory client that is rapidly approaching commercialization. This individual will play a critical role in strengthening QC operations as patient volume increases, serving as a hands-on lab expert while driving process improvements across ELISA, qPCR, and molecular assays. The ideal candidate thrives in fast-paced, high-growth environments, can quickly become a subject matter expert, and is passionate about improving training, reducing deviations, and building scalable QC processes. This is a highly visible role with direct impact on lab quality, readiness, and long-term success.Must-Haves:7+ years of quality control or related lab experience3 years of managerial experienceExperience with flow cytometry assaysBachelor's degree in a related fieldProven background in improving training, SOPs, and QC processesStrong, hands-on experience performing and reviewing assays, with deep expertise in assay processes and deviation analysis.Able to step in as an SME before scaling and leading a teamPlusses:Prior experience in a commercializing or near-commercial labLeadership experience building or mentoring QC teamsExperience in high-deviation or fast-growth lab environmentsStrong cross-functional communication with R&D and leadershipDay-to-Day:Provide daily supervision and technical leadership to QC analytical staffOversee and perform flow cytometry, molecular testing, and ELISA-based assaysEnsure testing supports Phase I/II, pivotal, and commercial programsReview, trend, and technically evaluate analytical data for compliance and integrityLead and support method qualification, validation, and transfer from Development to QCParticipate in investigations, deviations, OOS/OOTs, and CAPAsMaintain GMP documentation and adherence to SOPs and regulatory standardsAct as SME during regulatory inspections and client auditsSupport commercial readiness, lifecycle management, and reference standard characterizationPerform hands-on lab work as needed to support schedulesAssist with equipment, method, and process validation activitiesSupport inventory management, lab organization, and 5S complianceEnsure audit readiness and overall laboratory compliance