Senior IT Compliance Engineer - GxP & Quality (Remote)

Bristol Myers Squibb; Bothell (WA); Hybride; USD 99 000 - 121 000; Plein temps

Avantages offerts par ce poste

Flexible Time Off

11 paid holidays

Retirement and other benefits

Résumé du poste

Bristol Myers Squibb is seeking a Sr. Engineer, IT Compliance to lead compliance activities for GxP electronic systems. This role collaborates with Quality, Business Owners, and Technical Owners to ensure regulatory and procedural compliance across the system lifecycle.

The position requires 2+ years in Quality Systems and knowledge of global Health Authority regulations. It offers a collaborative environment, strong benefits, and opportunities for growth within a purpose-driven culture.

Qualifications

• Bachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.
• 2+ years of direct experience with Quality Systems (Deviations, CAPAs, Change Requests, SOPs) related activities, with a demonstrated understanding of electronic records / signatures and ALCOA+ data integrity.
• Strong knowledge of global Health Authority regulations, current industry practices, and experience with 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 MES, ERP, LIMS, Validation Lifecycle / Testing Software, QMS, Learning Management System

Responsabilités

• Lead compliance-related activities for GxP electronic systems and applications across their lifecycle.
• Partner with Quality, Business Owners, and Technical Owners to create and manage Quality Systems deliverables to ensure regulatory and procedural compliance.
• Perform / lead investigations and root cause analyses for Quality Event deviations related to IT systems.
• Manage working with contract resources as needed and support site integration efforts.
• Assist with governance boards as IT representative for regulatory compliance and participate in regulatory inspections as SME.

Connaissances

Quality Systems

Regulatory knowledge

IT compliance

GxP experience

Formation

Bachelor's degree in life sciences/engineering/technology

5+ years equivalent biotech/pharma experience

Outils

MES

ERP

LIMS

QMS

LMS

Description du poste

Bristol Myers Squibb is seeking a Sr. Engineer, IT Compliance to lead compliance activities for GxP electronic systems. This role collaborates with Quality, Business Owners, and Technical Owners to ensure regulatory and procedural compliance across the system lifecycle.

The position requires 2+ years in Quality Systems and knowledge of global Health Authority regulations. It offers a collaborative environment, strong benefits, and opportunities for growth within a purpose-driven culture.