Job Specifications
Job Title: Senior Data Integrity Consultant (GxP)
Location: San Diego, CA (On-site)
Position Type: Contract / Consultant
Department: Quality Assurance
Reports To: Site Quality Head / Director, QA
This is for the Poseida location in San Diego, CA.
Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed
About Us
Based in San Diego, our 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. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need.
Position Summary
The Quality organization is seeking an experienced Senior Data Integrity Consultant to join our team in San Diego, CA. In this on-site contracted role, you will be integral to the deployment and oversight of the site's Data Integrity (DI) program while providing expert Computer System Validation (CSV) leadership.
Reporting directly to the Site Quality Head, you will provide independent Quality oversight for all computerized systems, the Quality Management System (QMS), and associated paper-based systems. This role focuses on Quality Governance—ensuring that all data generated within laboratory, manufacturing, and quality environments is protected, attributable, accurate, and compliant with global regulatory expectations. You will act as the primary Quality voice for Data Integrity, ensuring technical and procedural controls are not only in place but are functioning effectively to meet company and international standards.
Key Responsibilities
Data Integrity Program Leadership
Lead the deployment, enhancement, and effective implementation of the site's Data Integrity program.
Conduct and execute gap assessments of data integrity practices, identifying risks and developing comprehensive site mitigation plans.
Ensure the Quality System satisfies compliance requirements associated with:
Data integrity regulations (FDA 21 CFR Part 11/211/820, EU Annex 11, EudraLex Volume 4)
Audit trail review and data governance
Data quality, backup, recovery, and security controls
Act as the primary Quality Assurance voice for DI standards, ensuring strict alignment with global quality expectations (e.g., Roche/Genentech PQS).
Provide expert QA oversight during the development of Solution Development Lifecycle (SDLC) documents (URS, Design Specs, Test Plans) to ensure DI and ALCOA+ principles are embedded at the architecture level.
Audit and approve the implementation of engineering controls, including audit trail configurations, restricted user access, and secure data mapping.
Validation & Computer Systems Assurance
Author, review, and approve critical validation deliverables, including:
Validation Plans, Risk Assessments, and User Requirements (URS)
Configuration Specifications, Test Scripts (IQ/OQ/PQ)
Validation Summary Reports and Periodic System Reviews
Perform requalification of existing computer systems and support periodic reviews to maintain a validated state.
Act as the Quality Lead for project teams, guiding the implementation of validation, security, and compliance deliverables throughout the system lifecycle.
Oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release and update.
Support evaluation and gap assessments of legacy systems for technical integration and remediation planning.
Operational Compliance & Audit Readiness
Lead and execute:
Periodic System Reviews (PSR): Evaluating the ongoing "state of control" and effectiveness of the system's data lifecycle.
User Account Reviews (UAR): Ensuring strict segregation of duties and appropriate GxP access levels.
Change Control Oversight: Leading Quality impact assessments to ensure changes do not compromise the validated state or data reliability.
Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA), and support the execution of corrective action plans.
Apply risk management processes to identify, mitigate, and escalate critical compliance findings or security risks to leadership.
Prepare management reports regarding compliance operations, project progress, and the overall validated state of site systems.
Continuous Improvement & Collaboration
Drive the enhancement of Quality Compliance operating procedures to bridge gaps between local manufacturing standards and global quality expectations.
Interface between local site manufacturing quality standards and global standards to ensure a unified compliance posture.
Act as a high-level consultant to technical SMEs, providing the "Quality lens" on complex data flow and system integration challenges.
Align daily actions with department goals and company cultu
About the Company
Founded in 2002, TalentBurst is an MBE and JCC certified firm that provides award winning solutions globally.
Services:
Banking, Financial Services, & Tech Staffing
Health & LifeScience Staffing
SLED (State, Local Gov, Education, Utility) Staffing
High Hazard & Global Payroll (EOR)
1099/IC Validation & Compliance (AOR)
Awards:
2004-2025 Newsweek Best Company for Diversity
2024-2025 USA Today Top Workplaces Best Place To Work
2024-2025 Newsweek America's Greatest Workplaces for Women
2024 Monster Top Workplaces for Remote ...
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