IT Compliance Engineer - Remote & Quality Systems Expert

Bristol Myers Squibb

Bothell (WA)

Hybrid

USD 99,000 - 121,000

Full time

8 days ago

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Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

Vacation & holidays

Insurance offerings

Job summary

Bristol Myers Squibb in Bothell, WA is seeking an Engineer, IT Compliance to lead cross-functional compliance activities for GxP electronic systems. The role focuses on Quality Systems deliverables across lifecycle, partnering with Quality, Business Owners, and Technical Owners to ensure regulatory compliance.

The position involves audits, investigations, and governance participation, with potential to manage contract resources and support site integration.

Qualifications

2+ years direct experience with Quality Systems (Deviations, CAPAs, Change Requests, SOPs).
Strong knowledge of global Health Authority regulations and IT compliance for computerized systems.
Experience with electronic records/signatures and ALCOA+ data integrity.

Responsibilities

Manage IT department metrics reporting tied to regulatory compliance and Quality Events.
Lead investigations and root cause analyses for Quality Event deviations related to IT systems.
Author/review Quality Systems records (Deviations, CAPAs, Change Requests, SOPs).
Collaborate with Quality, Business Owners, and Technical Owners on continuous improvement for IT-related Quality Events.
Perform periodic reviews of applicable SOPs.
Participate in governance boards as IT representative for regulatory compliance.
Support regulatory inspections as SME as needed.
Manage contract resources supporting IT compliance activities.
Assist with site integration and enterprise harmonization efforts.