Senior Data Integrity Consultant (GxP)

Location: San Diego, CA (On-site)Schedule: Monday–Friday, 8:00 AM–5:00 PM (flexibility for early/late hours as needed)Department: Quality Assurance About the Opportunity Join a cutting-edge, clinical-stage biopharmaceutical organization based in San Diego that is advancing next-generation cell and gene therapies. This organization leverages proprietary genetic engineering platforms to develop innovative CAR-T therapies for cancer and gene therapies for rare diseases—with the ultimate goal of delivering potential single-treatment cures. This is a unique opportunity to make a meaningful impact on patients’ lives while working in a fast-paced, mission-driven environment. Position Overview We are seeking a highly experienced Senior Data Integrity / Quality Assurance Consultant (GxP) to support on-site Quality operations in San Diego. In this contract role, you will play a critical leadership role in maintaining and enhancing local Quality Systems, with a strong emphasis on Quality Management Systems (QMS), Electronic Data Management Systems (EDMS), Document Control, and GxP compliance. This position is central to ensuring regulatory readiness and data integrity during periods of system integration and migration. You will work cross-functionally with Quality, Manufacturing, QC, Validation, Supply Chain, Facilities, and Clinical teams to support site-wide GxP activities. Key Responsibilities Provide QA leadership and support for legacy Quality Systems during QMS integration and system migration initiatives Support and oversee approximately 125 updated SOPs and manual/paper-based Quality systems Monitor, trend, and report Quality System metrics to reduce overdue records and ensure effective QMS controls Operate and maintain legacy Quality Systems during transition to new platforms Execute and manage Document Control activities for GxP documents, including manufacturing, clinical, and product quality records Support the GxP Training Program, including delivering training on GMP fundamentals, Change Control, Deviations, and CAPA Partner with Change Control, Deviation, MRB, and CAPA owners to ensure timely, compliant completion of quality records Perform operational activities within ComplianceWire (LMS) and Qualio (EDMS) Drive continuous improvement initiatives within EDMS and LMS processes Coordinate with document owners to ensure timely periodic review of procedures Author, revise, and improve SOPs, policies, forms, templates, and reporting tools Generate, analyze, and present Quality metrics and trends to leadership Support internal audits, partner audits, and regulatory inspections; assist with corrective action plans Review and approve paper-based and electronic Quality records Champion a culture of quality, collaboration, accountability, and patient-first thinking Align daily activities with departmental goals and organizational values Ability to lift up to 20 pounds as required Required Qualifications Education Bachelor’s degree in Life Sciences or a related discipline (or equivalent combination of education and experience) Experience Minimum of 8 years of experience in a regulated GxP environment (pharmaceutical, biotechnology, or cell/gene therapy manufacturing preferred) Technical Expertise Strong working knowledge of cGxP Quality Management Systems Hands-on experience with Change Control, Deviations, CAPA, Document Control, and Training systems Proficiency with EDMS and LMS platforms (e.g., ComplianceWire, Qualio) Advanced skills in Microsoft Excel, Word, and PowerPoint Core Competencies Excellent written and verbal communication skills Strong attention to detail with the ability to manage multiple priorities Proven ability to work independently and collaboratively in a dynamic environment Experience developing and delivering employee training Demonstrated expertise in writing and revising SOPs and Quality documentation This on-site contract role is ideal for a seasoned Quality professional passionate about data integrity, compliance excellence, and advancing life-changing therapies. #WCH Pay: $47.00 - $62.00 per hour Benefits: 401(k) Dental insurance Health insurance Life insurance Vision insurance Work Location: In person