Senior GxP Systems Analyst – Veeva Vault & QA

Katalyst-Healthcares-; Boston (MA); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Katalyst-Healthcares- seeks a Senior IT Business Analyst to support GxP computerized systems across QA, RA/Reg Ops, QC, Manufacturing, and Process Development. You will elicit user needs, translate to system requirements, and ensure validation, documentation, and data integrity across QMS platforms.

Collaborating with IT and business units, you will drive lifecycle activities, maintain inspection readiness, and provide high-level data insights while ensuring least-privilege access and secure

Formación

• 8-12 years of information systems business analysis experience.
• 5+ years supporting GxP-regulated environments with compliance-focused work.

Responsabilidades

• Act as primary BA for QA and RA/Reg Ops supporting GxP systems.
• Lead requirements elicitation and produce user stories, process maps, data flows, and specs.
• Coordinate validation activities including IQ/OQ/PQ and maintain validated state.

Conocimientos

GxP systems

CSV validation

Requirements elicitation

QA liaison

Regulatory Compliance

Educación

BS/BA in Information Systems or related

Master's degree preferred

Herramientas

QMS software

GAMP 5

Descripción del empleo

Katalyst-Healthcares- seeks a Senior IT Business Analyst to support GxP computerized systems across QA, RA/Reg Ops, QC, Manufacturing, and Process Development. You will elicit user needs, translate to system requirements, and ensure validation, documentation, and data integrity across QMS platforms.

Collaborating with IT and business units, you will drive lifecycle activities, maintain inspection readiness, and provide high-level data insights while ensuring least-privilege access and secure