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
• 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:

1. Leading Quality impact assessments to ensure changes do not compromise the validated state or data reliability.
2. Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA), and support the execution of corrective action plans.
3. Apply risk management processes to identify, mitigate, and escalate critical compliance findings or security risks to leadership.
4. 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.

Education & Experience

• Education: 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.

The hiring range for this position is $75 to $85 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.