Remote GxP IT Compliance Engineer | Quality & Regulatory

Bristol-Myers Squibb Co; Bothell (WA); Remote; USD 99,000 - 121,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

Company holidays

Job summary

Bristol Myers Squibb is seeking an Engineer, IT Compliance to lead compliance activities for GxP electronic systems across the site. You will collaborate with Quality, Business Owners, and Technical Owners to ensure regulatory and procedural compliance throughout the lifecycle of electronic systems and applications.

The role combines hands-on quality systems work with cross-functional governance, investigations, and supporting regulatory inspections.

Qualifications

• 2+ years of direct experience with Quality Systems (Deviations, CAPAs, Change Requests, SOPs)
• Strong knowledge of global Health Authority regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records and electronic signatures
• Strong knowledge of Quality Systems records documentation and metrics reporting
• Familiar with an array of computerized systems: MES, ERP, LIMS, Validation Lifecycle / Testing Software, QMS, Learning Management System

Responsibilities

• Manage department (IT) metrics reporting linked to regulatory compliance and Quality Events, including Deviations, CAPAs, Change Requests, Training, and completion of applicable procedural requirements
• Perform / lead investigations and root cause analyses for Quality Event deviations related to IT systems
• Author / contribute content, review and approve applicable Quality Systems records, including Deviations, CAPAs, Change Requests, SOPs, and others as needed
• Partner with Quality, and Business / Technical Owners on continuous improvement efforts to reduce or eliminate adverse trends related to Quality Events impactful to IT
• Perform periodic reviews of applicable SOPs
• Participate in governance boards, acting as the IT representative for regulatory and procedural compliance
• Support regulatory inspections as a subject matter expert (SME) as needed
• Manage supporting contract resources as needed
• Assist with site integration and enterprise harmonization activities as applicable

Skills

Quality Systems

Regulatory knowledge

Data integrity ALCOA+

GxP IT compliance

Computerized systems

Education

Bachelor's degree in a life sciences, engineering, or technology discipline

Tools

MES

ERP

LIMS

QMS

Validation Lifecycle

Testing Software

Job description

Bristol Myers Squibb is seeking an Engineer, IT Compliance to lead compliance activities for GxP electronic systems across the site. You will collaborate with Quality, Business Owners, and Technical Owners to ensure regulatory and procedural compliance throughout the lifecycle of electronic systems and applications.

The role combines hands-on quality systems work with cross-functional governance, investigations, and supporting regulatory inspections.