Quality Systems Engineer – GxP & Data Integrity

Katalyst CRO; Boston (MA); On-site; Full time

Job description

Job Summary

The Quality Engineer will support the Quality Information Systems Management (QISM) group by providing quality oversight for computerized system projects across Manufacturing, Laboratory, and Enterprise platforms. This role will collaborate with cross‑functional teams to ensure compliance with data integrity, validation, regulatory, and quality requirements throughout the system lifecycle, including implementation, enhancements, releases, and periodic reviews.

Roles & Responsibilities

• Provide Quality oversight for enterprise computerized systems including ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, Data Analytics platforms, Manufacturing Systems, and Laboratory Systems.
• Participate in and support cross‑functional project discussions, offering quality guidance and compliance decisions for new implementations, enhancements, quarterly releases, and periodic reviews.
• Review and approve quality events such as deviations, CAPAs, validation documents, test scripts, execution results, reports, and traceability matrices.
• Drive system assessments and support issue resolution activities while ensuring adherence to GxP and quality compliance standards.
• Ensure Data Integrity principles are implemented and maintained throughout computerized system projects.
• Identify quality risks, recommend mitigation strategies, and communicate findings to project teams and quality management.
• Perform and communicate quality assurance activities across all phases of system development and implementation.
• Support Agile and GAMP5 validation lifecycle activities and maintain proper process documentation.

Education & Experience

• Bachelor's degree in information technology, Computer Science, or related field.
• 610+ years of experience in computerized systems validation and quality assurance within regulated environments.
• Strong knowledge of GAMP5, ITIL, Data Integrity, and validation lifecycle methodologies.
• Experience with enterprise systems, manufacturing systems, and laboratory systems validation.
• Familiarity with Agile methodologies, Application Lifecycle Management (ALM), and e‑signature systems.
• Strong analytical, technical writing, communication, and project coordination skills.
• Experience with Veeva Vault QMS, ServiceNow, and ALM systems is highly preferred.
• Ability to work effectively in a hybrid onsite environment and collaborate with cross‑functional teams.