New 
Senior Computer System Validation Consultant (GxP)
 Spectraforce Technologies | |
 United States, California, San Diego | |
 Apr 02, 2026 | |
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Position Title: Senior Computer System Validation Consultant (GxP) Work Location: San Diego, CA (On-site) Assignment Duration: 6 months (possibility of extension) Position Summary: The Quality organization is seeking an exceptional consultant/contracted specialist to join our Quality team in San Diego, CA. This is an on-site role that will lead the enhancement and maintenance of the computer system validation program. Background & Context: Based in San Diego, the site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. Key Responsibilities: * Deliverable Management: Author, review, and approve critical validation deliverables, including Validation Plans, Risk Assessments, User Requirements (URS), Configuration Specifications, Test Scripts (IQ/OQ/PQ), and Validation Summary Reports. Perform requalification of existing computer systems and support periodic reviews of computer systems. * System Development Oversight: Define and oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release, update, or iteration. * Project Guidance: Act as the Quality Lead for project teams, guiding the implementation of validation, security, and project management deliverables at appropriate stages of the system lifecycle. * System Oversight: Review and approve system lifecycle documentation generated by project teams to ensure alignment with local SOPs and global regulatory expectations. * Audit & Inspection Support: Lead or contribute significantly to internal and external audits, assessments, and compliance plans to support future Health Authority inspections (FDA/EMA). * Risk Management: Apply thorough knowledge of risk management processes to identify, mitigate, and escalate critical compliance findings or security risks to appropriate leadership. * Reporting: Prepare management reports regarding compliance operations, project progress, and the overall validated state of site systems. * Support evaluation of existing legacy systems for technical integration and tool management. * Perform gap assessments and risk assessments on legacy systems, as required. * Advise project teams on the implementation of compliance and security control requirements to ensure data integrity and system reliability are integrated by design. * Align daily actions with department goals and company culture * Actively promote teamwork across all functions with focus on our patients being the top priority * Drives, fosters and embraces an environment of teamwork, accountability and responsibility that supports the manufacture of a quality product Qualification & Experience: * Bachelor's degree in Life Sciences discipline with the Life Sciences industry (Consulting or Industry) with a focus on CSV and Quality Compliance. * Regulatory Knowledge Expert understanding of 21 CFR Part 11, GxP (211/820), GAMP 5, and EU Annex 11. * Technical Background Strong IT/Technical background to understand the complexities of networked programs and infrastructure. * System Tools Familiarity with laboratory, manufacturing, and quality management systems for GMP operations. Fluency in quality management systems for managing validation and change records. * Soft Skills Excellent communication, collaborative attitude, and the ability to manage multiple projects in a complex environment. * Complete proficiency in Excel, PowerPoint and Word. Fluency with advanced/expert knowledge in data integrity and computer systems for cell and gene therapy / biotech / pharmaceutical applications. * Demonstrated ability to work independently, within prescribed guidelines, or as a team member * Strong knowledge and competence in the utilization of core quality systems such as Change Control, Deviations, CAPA management, Document Control, Training, EDMS and LMS systems Additional Information: Based in San Diego, the site operates as a clinical-stage biopharmaceutical facility utilizing genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. The organization focuses on developing CAR-T therapies in various cancers and gene therapies for rare diseases, with the goal of delivering potential single treatment cures for patients in need. | |