Biotech IT Compliance Lead — Data Integrity

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

Avantages offerts par ce poste

Flexible Time Off

Paid holidays

Vacation policy

Résumé du poste

Bristol Myers Squibb in Bothell, WA seeks a Lead Engineer, IT Compliance, Data Integrity to drive GxP system compliance and data integrity across manufacturing, quality and lab operations. You will collaborate with IT, QA, and manufacturing teams to lead risk assessments, change control, and regulatory readiness in a highly regulated biotech environment.

The role emphasizes cross-functional learning, digital transformation, and continuous improvement with mentorship for team members.

Qualifications

• Bachelor's degree in a related field and experience with IT Compliance applications.
• 5+ years hands-on experience in biotech manufacturing and supply chain.
• Knowledge of cGMP, GXP, GAMP, SDLC and 21 CFR 11.
• Familiarity with MES, eQMS, SAP/Oracle systems and regulatory readiness.

Responsabilités

• Lead IT compliance and data integrity programs for GxP systems.
• Facilitate DIRAs, QRAs, system impact assessments and compliance evaluations.
• Lead investigations, root cause analyses, CAPA, and effectiveness monitoring.
• Support CSV activities and system lifecycle validation.
• Lead internal audits and regulatory inspection readiness activities.

Connaissances

Technical leadership

Communication

GxP compliance

Data integrity

Regulatory knowledge

Formation

Bachelor's degree in IT/Engineering

Outils

MES

eQMS

ServiceNow

SAP

Oracle

JIRA

Description du poste

Bristol Myers Squibb in Bothell, WA seeks a Lead Engineer, IT Compliance, Data Integrity to drive GxP system compliance and data integrity across manufacturing, quality and lab operations. You will collaborate with IT, QA, and manufacturing teams to lead risk assessments, change control, and regulatory readiness in a highly regulated biotech environment.

The role emphasizes cross-functional learning, digital transformation, and continuous improvement with mentorship for team members.