Senior Computer System Validation Consultant

Position Title: Senior Computer System Validation Consultant (GxP)

Work Location: San Diego, CA, 92111

Assignment Duration: 6 Months

Work Arrangement: On-site

Position Summary: The Quality organization is seeking an exceptional consultant/contracted specialist to join our Quality team in San Diego, CA. This is an on-site role that will lead the enhancement and maintenance of the computer system validation program. As the CSV Quality SME, you will provide critical Quality Assurance oversight and technical validation expertise for computerized systems within the San Diego site and environment.

Background & Context: Based in San Diego, the 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.

Key Responsibilities:

Validation Lifecycle & Governance

• Deliverable Management: Author, review, and approve critical validation deliverables, including Validation Plans, Risk Assessments, User Requirements (URS), Configuration Specifications, Test Scripts (IQ/OQ/PQ), and Validation Summary Reports.
• Perform requalification of existing computer systems and support periodic reviews of computer systems.
• System Development Oversight: Define and oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release, update, or iteration.
• Project Guidance: Act as the Quality Lead for project teams, guiding the implementation of validation, security, and project management deliverables at appropriate stages of the system lifecycle.

Operational Compliance & Audit Readiness

• System Oversight: Review and approve system lifecycle documentation generated by project teams to ensure alignment with local SOPs and global regulatory expectations.
• Audit & Inspection Support: Lead or contribute significantly to internal and external audits, assessments, and compliance plans to support future Health Authority inspections (FDA/EMA).
• Risk Management: Apply thorough knowledge of risk management processes to identify, mitigate, and escalate critical compliance findings or security risks to appropriate leadership.
• Reporting: Prepare management reports regarding compliance operations, project progress, and the overall validated state of site systems.

Technical Integration & Tool Management

• Support evaluation of existing legacy systems for technical integration and tool management.
• Perform gap assessments and risk assessments on legacy systems, as required.
• Security & Control: Advise project teams on the implementation of compliance and security control requirements to ensure data integrity and system reliability are integrated by design.

Other Responsibilities:

• Align daily actions with department goals and company culture.
• Actively promote teamwork across all functions with focus on our patients being the top priority.
• Drives, fosters and embraces an environment of teamwork, accountability and responsibility that supports the manufacture of a quality product.

Qualification & Experience:

• Bachelor's degree in Life Sciences discipline with the Life Sciences industry (Consulting or Industry) with a focus on CSV and Quality Compliance.
• Regulatory Knowledge: Expert understanding of 21 CFR Part 11, GxP (211/820), GAMP 5, and EU Annex 11.
• Technical Background: Strong IT/Technical background to understand the complexities of networked programs and infrastructure.
• System Tools: Familiarity with laboratory, manufacturing, and quality management systems for GMP operations. Fluency in quality management systems for managing validation and change records.
• Soft Skills: Excellent communication, collaborative attitude, and the ability to manage multiple projects in a complex environment.
• Complete proficiency in Excel, PowerPoint and Word. Fluency with advanced/expert knowledge in data integrity and computer systems for cell and gene therapy / biotech / pharmaceutical applications.
• Demonstrated ability to work independently, within prescribed guidelines, or as a team member.
• Strong knowledge and competence in the utilization of core quality systems such as Change Control, Deviations, CAPA management, Document Control, Training, EDMS and LMS systems.