GLP Quality Assurance Specialist

RPM ReSearch•San Diego, CA

11d•Onsite

About The Position

This role offers significant influence in building the quality system for a growing neuroscience-focused CRO that supports advanced devices and cell and gene therapies. The organization develops precise navigation solutions for the brain and spine and supports therapy development from preclinical work through clinical application. The San Diego CRO is expanding within an established company, conducting GLP and non-GLP studies, neurosurgical and infusion support, safety and toxicology studies, compatibility testing, advanced imaging, and translational research. The position is the primary onsite quality presence, working closely with experienced quality leadership to build the Quality Assurance Unit and prepare for full GLP studies. The role involves determining priorities, identifying gaps, conducting facility audits, improving processes, supporting validation, and participating in the implementation of Provantis. The environment combines startup energy with the resources of an established organization.

Requirements

A bachelor’s degree in a scientific, quality, regulatory, or related field, or an equivalent combination of education and relevant experience.
Meaningful experience in an FDA GLP-regulated environment and a working understanding of 21 CFR Part 58.
Experience inside a nonclinical CRO or a closely related preclinical research organization.
Typically three or more years in Quality Assurance or a related GLP function.
Sound judgment and the ability to apply GLP requirements through thoughtful risk assessment rather than rigid interpretation.
Strong documentation, analytical, and problem-solving skills with careful attention to accuracy.
Communication skills to work through difficult quality issues with scientists, study teams, laboratory staff, veterinarians, and leaders.
Initiative to work effectively in an evolving environment where every process has not yet been fully defined.
Ability to work full time onsite in San Diego.
Direct GLP exposure is required. A GMP-only quality background will generally not provide the regulatory context needed for this role.

Nice To Haves

Direct experience performing GLP facility, process, study, data, report, or critical-phase audits.
Equipment qualification or computerized-system validation experience.
Experience with Provantis or another laboratory information management system.
Experience with electronic quality management systems, data integrity, audit trails, or 21 CFR Part 11.
Document control or regulated archives experience.
Experience supporting in vivo studies, surgical research, medical devices, radiation studies, or advanced therapies.
RQAP-GLP certification or an interest in working toward certification.
Developed regulatory judgment in an adjacent CRO role (e.g., study coordination, study support, report writing, archives, document control, clinical pathology, laboratory operations, validation, or study direction) and a desire to build a career in quality.

Responsibilities

Review and approve study documentation, data, reports, protocols, methods, forms, and quality records.
Conduct or support critical-phase inspections, facility audits, process audits, and internal study audits.
Help assess GLP readiness and complete gap analyses as the CRO moves toward full GLP study capability.
Partner with research teams to develop practical, compliant protocols, methods, forms, and operating processes.
Support equipment and computerized-system validation, including 21 CFR Part 11 considerations.
Contribute to the implementation and validation of Provantis and other electronic quality or laboratory systems.
Track, trend, and evaluate deviations, nonconformances, and corrective and preventive actions.
Maintain accurate quality records and take on selected document-control and archival responsibilities.
Assist with GLP and regulatory training, with the opportunity to lead training.
Translate audit findings and quality trends into practical process improvements.
Maintain the independence required of Quality Assurance while remaining an approachable and constructive member of the broader team.
Travel occasionally for supplier or offsite audits as the quality program expands.