Job Details

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 experience
• 3 years of managerial experience
• Experience with flow cytometry assays
• Bachelor's degree in a related field
• Proven background in improving training, SOPs, and QC processes
• Strong, 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 team

Plusses:

• Prior experience in a commercializing or near-commercial lab
• Leadership experience building or mentoring QC teams
• Experience in high-deviation or fast-growth lab environments
• Strong cross-functional communication with R&D and leadership

Day-to-Day:

• Provide daily supervision and technical leadership to QC analytical staff
• Oversee and perform flow cytometry, molecular testing, and ELISA-based assays
• Ensure testing supports Phase I/II, pivotal, and commercial programs
• Review, trend, and technically evaluate analytical data for compliance and integrity
• Lead and support method qualification, validation, and transfer from Development to QC
• Participate in investigations, deviations, OOS/OOTs, and CAPAs
• Maintain GMP documentation and adherence to SOPs and regulatory standards
• Act as SME during regulatory inspections and client audits
• Support commercial readiness, lifecycle management, and reference standard characterization
• Perform hands-on lab work as needed to support schedules
• Assist with equipment, method, and process validation activities
• Support inventory management, lab organization, and 5S compliance
• Ensure audit readiness and overall laboratory compliance