Senior Data Integrity Consultant (GxP)

Senior Data Integrity Consultant (GxP) ROCGJP00039853

• Hourly pay: $85/hr
• Worksite: Leading biotechnology company (San Diego, CA 92121 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 6 Month Assignment

A leading biotechnology company is seeking a Senior Data Integrity Consultant (GxP) for their clinical-stage biopharmaceutical facility that creates next-generation cell and gene therapies with the capacity to cure, making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. The Senior Data Integrity Consultant will be integral to the deployment and oversight of the site's Data Integrity (DI) program while providing expert Computer System Validation (CSV) leadership.

Senior Data Integrity Consultant (GxP) Responsibilities:

• Provide independent Quality oversight for all computerized systems, the Quality Management System (QMS), and associated paper-based systems.
• Ensure that all data generated within laboratory, manufacturing, and quality environments is protected, attributable, accurate, and compliant with global regulatory expectations.
• 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.
• 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).
• 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.
• 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.
• 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.

Senior Data Integrity Consultant (GxP)Qualifications:

• 8+ years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred), with a focus on Data Integrity, Computer System Validation, and Quality Compliance.
• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline (an equivalent combination of education and experience may be considered).
• Expert understanding of: FDA 21 CFR Part 11, 210/211, and 820, EU EudraLex Volume 4 (Annex 11 and Chapter 4), GAMP 5 and risk-based validation approaches, ALCOA+ principles and data governance frameworks
• Strong knowledge of Quality Management Systems in a cGxP manufacturing environment.
• Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.
• Hands-on experience with Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), and laboratory/manufacturing systems..
• Experience developing training materials and delivering training to employees on DI and CSV topics.
• Ability to lift up to 20 pounds as needed.

Shift:

• Standard hours 8am to 5pm - some flexibility to work earlier/late as needed.