Senior Data Integrity Consultant

Avispa Technology•San Diego, CA

16h•Onsite

About The Position

A leading biotechnology company is seeking a Senior Data Integrity Consultant to lead and oversee Data Integrity (DI) and Computer System Validation (CSV) initiatives within a clinical-stage manufacturing environment. This role will provide Quality oversight of computerized systems, ensuring data accuracy, security, and compliance with global regulatory standards to support cell and gene therapy development.

Requirements

8+ years of experience in a GxP-regulated environment (pharma, biotech, or cell/gene therapy), with a strong focus on Data Integrity, CSV, and Quality Compliance.
Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field (or equivalent experience).
Expert knowledge of FDA regulations (21 CFR Part 11, 210/211/820), EU Annex 11, EudraLex Volume 4, GAMP 5, and ALCOA+ data integrity principles.
Hands-on experience with Quality Management Systems (QMS), including Change Control, Deviations, CAPA, Document Control, Training systems, and electronic systems (EDMS, LMS, lab/manufacturing platforms).
Strong technical writing, communication, and analytical skills, with the ability to manage multiple projects, work independently, deliver training, and support audits in a fast-paced environment.

Responsibilities

Lead the deployment and continuous improvement of the site’s Data Integrity program, conducting gap assessments, developing mitigation plans, and ensuring compliance with FDA (21 CFR Part 11/210/211/820), EU Annex 11, ALCOA+ principles, and global quality standards.
Provide Quality oversight for computerized systems and SDLC documentation (URS, design specs, test plans), ensuring data governance, audit trails, security controls, and system architecture meet regulatory and internal requirements.
Author, review, and approve validation deliverables (IQ/OQ/PQ, validation plans, risk assessments, summary reports), support system requalification and periodic reviews, and guide project teams through compliant system lifecycle execution.
Drive operational compliance through activities such as periodic system reviews, user access reviews, and change control oversight, while leading or supporting internal/external audits and regulatory inspections (FDA/EMA) and managing CAPA and risk mitigation efforts.
Collaborate cross-functionally to enhance quality systems and procedures, support integration of local and global standards, provide expert consultation on data and system challenges, deliver training on DI/CSV practices, and prepare reports on compliance status and system performance.