IT Compliance & Data Integrity Lead – Biotech

Bristol-Myers Squibb Co; Bothell (WA); Sur place; USD 118 000 - 143 000; Plein temps

Résumé du poste

Bristol Myers Squibb is seeking a Lead Engineer, IT Compliance, Data Integrity for the Bothell, WA manufacturing site. This individual contributor role supports GxP computerized systems, drives DIRAs/QRAs, and collaborates with IT, Quality, Manufacturing, and Validation teams to ensure regulatory compliance and continuous improvement.

The position emphasizes training development, change management, and data-driven insights to enhance performance and compliance in a highly regulated environment

Qualifications

• Experience with IT compliance applications in biotech/manufacturing environments.
• 5+ years in biotech manufacturing and supply chain settings.
• Knowledge of cGMP, GXP, SDLC and 21 CFR Part 11.

Responsabilités

• Lead IT compliance and data integrity programs for GxP systems in cell therapy operations.
• Oversee DIRAs, QRAs, system impacts, and compliance evaluations.
• Drive validation activities across system lifecycle and risk assessments.
• Support audits, inspections, CAPA, deviation and change control processes.
• Develop training programs and learning strategies for compliance adoption.

Connaissances

IT compliance

Data integrity

GxP systems

Regulatory compliance

cGMP/GXP knowledge

SDLC

Quality risk assessments

Change control

Audit readiness

SQL/Analytics

Formation

Bachelor's degree in IT / Engineering / Life Sciences

Outils

CSV

eQMS

SAP

Oracle

JIRA

Description du poste

Bristol Myers Squibb is seeking a Lead Engineer, IT Compliance, Data Integrity for the Bothell, WA manufacturing site. This individual contributor role supports GxP computerized systems, drives DIRAs/QRAs, and collaborates with IT, Quality, Manufacturing, and Validation teams to ensure regulatory compliance and continuous improvement.

The position emphasizes training development, change management, and data-driven insights to enhance performance and compliance in a highly regulated environment