GLP Quality Assurance Specialist

Quality Assurance SpecialistHelp build the quality system behind a growing neuroscience focused CRO supporting advanced devices and cell and gene therapies.RPM ReSearch is conducting a search for a Quality Assurance Specialist on behalf of a global medical technology and advanced-therapy company. The organization develops precise navigation solutions for the brain and spine and supports therapy development from early preclinical work through clinical application. Its technology has supported thousands of procedures and collaborations with neuroscience centers and biologics partners around the world.The San Diego CRO is growing inside an established company. Its work includes GLP and non-GLP studies, neurosurgical and infusion support, safety and toxicology studies, compatibility testing, advanced imaging, and translational research involving medical devices, radiation, cell therapy, gene therapy, and targeted drug delivery.Why this opportunity is differentThis role offers far more influence than the title may suggest. You will become the primary onsite quality presence for the San Diego CRO and work closely with an experienced quality leader who is building the Quality Assurance Unit and preparing the operation for full GLP studies.The systems are still taking shape. You will help determine priorities, identify gaps, conduct facility audits, improve processes, support validation, and participate in the implementation of Provantis. The environment has the energy and access of a startup while benefiting from the resources and stability of an established organization.Serve as the day-to-day onsite quality partner for a collaborative scientific and operational team.Help create and improve a GLP quality system instead of simply maintaining a mature one.Gain exposure to specialized neuroscience, surgical, imaging, device, and advanced-therapy research.Work directly with quality leadership, Test Facility Management, study directors, veterinary medicine, and laboratory teams.Receive support for Society of Quality Assurance participation, continuing education, and future RQAP-GLP certification.Grow with the Quality Assurance Unit, with a realistic path toward broader responsibility and future leadership as the CRO expands.What you will doReview 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 while the operating teams retain responsibility for authoring them.Maintain accurate quality records and take on selected document-control and archival responsibilities as the program develops.Assist with GLP and regulatory training, with the opportunity to lead training as your knowledge of the site grows.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.What success will look likeTime frameExpected contributionFirst 30 daysLearn the operation, build relationships, help establish GLP-readiness priorities, contribute to gap analysis, and begin facility audits.First 90 daysTake increasing ownership of internal audits, quality records, validation support, and quality-system improvement projects.First yearOperate confidently as the onsite QA representative, complete and close a meaningful group of facility audits, and help implement new processes based on the findings.What you bringA 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. Candidates with less direct auditing experience may be considered when they bring strong GLP-CRO experience from an adjacent role.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.The communication skills to work through difficult quality issues with scientists, study teams, laboratory staff, veterinarians, and leaders.The initiative to work effectively in an evolving environment where every process has not yet been fully defined.The ability to work full time onsite in San Diego.Important fit consideration This position requires direct GLP exposure. A GMP-only quality background will generally not provide the regulatory context needed for this role.Experience that would be especially valuableDirect 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.A path into Quality AssuranceStrong candidates may already be working in GLP Quality Assurance. The team will also consider people who developed their regulatory judgment in an adjacent CRO role and want to build a career in quality. Relevant backgrounds may include study coordination, study support, report writing, archives, document control, clinical pathology, laboratory operations, validation, or study direction. The common requirement is real experience working within GLP studies and understanding how documentation, systems, operations, and QA fit together.The working environmentThe San Diego team is close, accountable, and comfortable learning in public. People are expected to raise concerns, offer ideas, acknowledge mistakes, and help solve problems. Quality Assurance is expected to remain independent, but it is not expected to operate as the police. The best fit will know when to be firm, when to ask questions, and how to help a team reach a compliant answer together.The CRO is still being built, and the successful candidate should expect changing priorities and occasional ambiguity. For someone who wants visibility, access to leadership, and the chance to shape how quality operates, that unfinished environment is the opportunity.Compensation and locationBase salary of $85,000 to $100,000, based primarily on the depth of GLP-CRO and quality experience.Full-time, permanent position based onsite at the Torrey Pines location in San Diego, California.Local candidates are preferred, and relocation assistance may be available for the right person.Limited future travel, generally a few offsite audits per year.About RPM ReSearchRPM ReSearch recruits scientific, quality, operational, veterinary, and commercial leaders across preclinical and clinical research. Our process begins with a detailed conversation so candidates can understand the work, the manager, the environment, and the tradeoffs before deciding whether to move forward.If this role fits your experience, or if you have built your GLP knowledge in an adjacent CRO position and are ready to move into Quality Assurance, we would welcome a conversation.Take a look at the area:San Diego Biotech Relocation Neighborhood Strategy - Watch Video