Quality Control Manager-Department of Neurosurgery-GMP Lab

Job Details

Quality Control Manager-Department of Neurosurgery-GMP Lab

Job No: 539849
Work Type: Full Time
Location: Main Campus (Gainesville, FL)
Categories: Biology/Life Science, Office/Administrative/Fiscal Support, Health Care Administration/Support
Department: 29190000 - MD-NEUROLOGICAL SURGERY

Job Description

Classification Title:
Research & Development Manager

Classification Minimum Requirements:
Master's degree in an appropriate area and seven years of relevant experience.

Job Description:

QC Laboratory Operations & Compliance

• 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.

Team Leadership & Lab Oversight

• 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.

Cross-Functional Collaboration

Partner closely with Manufacturing, Facilities, and Quality Assurance to align testing priorities with production schedules, investigations, batch disposition needs, and facility monitoring requirements.

Expected Salary:
$96,350-$110,700

Required Qualifications:
Master's degree in an appropriate area and seven years of relevant experience.

Preferred:

• 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, sterilityrelated 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

Special Instructions to Applicants:
For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references.
The University of Florida is an Equal Employment Opportunity Employer.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:
Yes

Applications Close: 22 May 2026