QA - Data Integrity Consultant

Dawar Consulting•San Diego, CA

About The Position

We are seeking an experienced Senior Data Integrity Consultant (GxP) to support and enhance Quality Systems at our clinical -stage biopharmaceutical facility. This role will focus on maintaining and improving the Quality Management System (QMS), Electronic Document Management Systems (EDMS), and overall data integrity processes in a regulated environment. The consultant will collaborate with cross -functional teams including QA, QC, Manufacturing, Validation, Supply Chain, and Clinical Operations to ensure compliance with Good Manufacturing Practice and other GxP regulations while supporting operational quality processes.

Requirements

Bachelor’s degree in Life Sciences or related discipline.
8+ years of experience in a GxP -regulated pharmaceutical or biotechnology environment.
Strong experience with Quality Management Systems (QMS) and quality processes.
Hands -on experience with EDMS and LMS platforms.
Experience supporting audits, compliance activities, and SOP managementTechnical Skills
Strong knowledge of Good Manufacturing Practice/ GxP quality systems
Experience with Change Control, Deviations, CAPA, and Document Control
Experience using Qualio and ComplianceWire

Responsibilities

Support and maintain Quality Systems including Change Control, Deviations, CAPA, Training, and Document Control.
Provide QA oversight for document management and legacy quality systems during system integration and migration.
Manage and maintain GxP documentation within EDMS platforms such as Qualio and training systems such as ComplianceWire.
Monitor and report quality metrics, ensuring timely closure of quality records and compliance with internal procedures.
Assist in the development, revision, and management of SOPs, policies, and controlled documents.
Support internal and external audits and contribute to corrective and preventive action plans.
Deliver training on Quality System topics including GMP, Change Control, Deviations, and CAPA processes.
Collaborate with cross -functional teams to promote data integrity, compliance, and continuous improvement.