Thorough Group is partnering with a growing life sciences company to hire a GLP Quality Assurance Lead. Our client uses advanced cell-based models to support preclinical safety and toxicity testing.
The role reports directly to the CEO / Managing Director, with the Quality Assurance Unit (QAU) operating independently of laboratory operations. The core mandate is to manage and maintain the Quality Management System (QMS), oversee personnel training, and lead quality assurance for studies and archiving.
This is a hands-on role. You’ll draft SOPs, manage document control, and audit studies while building the processes and team needed to grow the QA function over time.
Key responsibilities
Manage and maintain the QMS
- Partner with external GLP consultants to bring the existing QMS into routine use, then own its maintenance and continuous improvement.
- Draft and revise SOPs and manage the lifecycle of controlled documents, including protocols, study plans, forms, and validation reports. Maintain version control, review schedules, and archival records.
- Lead investigations into deviations, nonconformances, and client complaints. Manage root cause analysis and corrective and preventive actions (CAPA) through closure.
Lead independent study quality assurance
- Build and lead the QAU and maintain the facility master schedule for GLP and non-GLP studies, including study phases and test sites.
- Inspect critical phases of cell-based studies, including assay setup, test article handling, tissue dosing, and endpoint measurements.
- Audit raw data and draft final reports for accuracy, integrity, and compliance. Prepare and sign QAU statements for final GLP study reports.
Oversee training and archiving
- Manage GLP, Good In Vitro Method Practices (GIVMP), and SOP training. Verify that personnel are qualified before they perform work independently and maintain inspection-ready training records.
- Serve as or designate the master archivist. Oversee the secure storage and retrieval of study records, raw data, specimens, and historical QMS documentation.
- Oversee quality processes for laboratory equipment calibration and qualification, computerized system validation, and critical supplier qualification.
Represent Quality with clients and regulators
- Serve as the primary QA contact for biopharma clients. Manage pre-study quality assessments, compliance questionnaires, and quality agreements.
- Lead client audits, coordinate inspection readiness, and represent the company’s quality function during regulatory inspections. Draft formal responses and CAPA plans for findings.
Required qualifications:
- 7–10 years of direct quality assurance experience in GLP-regulated environments. Prior CRO experience is required.
- Expert knowledge of FDA GLP and hands-on experience applying it in cell-based or in vitro laboratory environments, such as 3D cellular models, spheroids, organoids, microphysiological systems, or cell-based toxicity assays.
- Working knowledge of GIVMP and its application to preclinical safety studies.
- Direct experience drafting SOPs, managing controlled documents, auditing studies, and overseeing training, CAPA, and archiving.
- Experience leading client audits and preparing laboratory facilities for regulatory inspections.
- Ability to operate independently, communicate findings directly to executive leadership, and grow the QA function as the organization expands.
- Bachelor’s or master’s degree in cell biology, biochemistry, toxicology, or a related life sciences discipline.
Preferred qualifications:
- Prior experience hosting or supporting FDA GLP inspections, including representing the quality function directly to inspectors.
- RQAP-GLP certification through the Society of Quality Assurance is strongly preferred.
- Experience with electronic document management or quality management systems.
- Familiarity with microfluidics, high-content imaging, transcriptomics, or multi-endpoint in vitro safety screening.
- Familiarity with regulatory initiatives related to new approach methodologies (NAMs) and non-animal testing.