Quality Control Manager-Department of Neurosurgery-GMP Lab

University of Florida•Gainesville, FL

About The Position

This position serves as the Quality Control Manager within the Department of Neurosurgery's GMP Lab. The role involves leading day-to-day operations of the QC laboratory to support in-process, release, and stability testing for GMP clinical materials. Key responsibilities include authoring and implementing SOPs, reviewing laboratory documentation, leading investigations, and supporting method qualification and assay implementation. The manager will also supervise QC staff, oversee the environmental monitoring program, and ensure laboratory equipment readiness. Collaboration with Manufacturing, Facilities, and Quality Assurance is essential to align testing priorities with production schedules and other critical functions.

Requirements

Master's degree in an appropriate area
Seven years of relevant experience

Nice To Haves

Working knowledge of cGMP, GLP, GDP, deviation management, investigations, CAPA, change control, and data integrity principles.
Minimum 5-8 years of relevant experience in a GMP-regulated biopharmaceutical, biotechnology, cell therapy, gene therapy, or CDMO environment, including progressive QC laboratory responsibilities.
Prior experience supporting cell therapy, gene therapy, immunotherapy, or other advanced therapy products.
Hands-on experience with cell-based assays, flow cytometry, PCR/qPCR, molecular assays, sterility-related testing support, and/or potency-related assay.
Experience with environmental monitoring in classified cleanroom environments.
Experience with method transfer, qualification, validation support, and assay lifecycle management.
Prior experience supervising or mentoring laboratory personnel.
Excellent attention to detail and commitment to data integrity.
Strong written and verbal communication skills.

Responsibilities

Lead day-to-day operations of the QC laboratory in support of in-process, release, and stability testing for GMP clinical materials.
Author, revise, and implement SOPs, specifications, forms, protocols, reports, and laboratory documentation to maintain a robust and scalable QC system.
Review and approve laboratory records, test results, logbooks, worksheets, protocols, reports, and other controlled documentation for completeness, accuracy, and compliance.
Lead or support laboratory investigations related to OOS, OOT, deviations, atypical results, excursions, and CAPA.
Support method qualification, transfer, validation readiness, and new assay implementation as programs evolve.
Supervise QC staff, including training, scheduling, workload prioritization, performance management, and technical development.
Support the environmental monitoring program for classified GMP spaces, including scheduling, trend review, documentation, and collaboration with Facilities and QA on excursions and corrective actions.
Oversee laboratory equipment readiness, maintenance, calibration, qualification, and troubleshooting coordination to ensure an inspection-ready QC operation.
Partner closely with Manufacturing, Facilities, and Quality Assurance to align testing priorities with production schedules, investigations, batch disposition needs, and facility monitoring requirements.