Senior Data Integrity Consultant

Position Title: Senior Data Integrity Consultant (GxP)

Work Location: San Diego, CA, 92111

Assignment Duration: 6 Months

Work Arrangement: On-site

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.

Background & Context:

This is for the Poseida location in San Diego, CA. 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.

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.

* 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 culture, actively promoting teamwork across all functions with a patient-first mindset.

Qualification & Experience:

Education & Experience

* Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline (an equivalent combination of education and experience may be considered).

* Minimum of 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.

Regulatory Knowledge

* 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.

Technical Skills

* 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.

* Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).

Competencies

* Exceptional written and verbal communication skills, with the ability to author and revise SOPs, work instructions, and validation documents.

* Strong attention to detail and ability to manage multiple projects simultaneously in a fluid, dynamic, and fast-paced environment.

* Proven ability to work independently, within prescribed guidelines, or as part of a collaborative team.

* Experience developing training materials and delivering training to employees on DI and CSV topics.

* Ability to lift up to 20 pounds as needed.

Working Conditions & Physical Demands (If Applicable):

Ability to lift up to 20 pounds as needed. Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed.