Senior IT Compliance Engineer (GxP Systems)

Bristol-Myers Squibb Company; Bothell (WA); Sur place; USD 99 000 - 121 000; Plein temps

Avantages offerts par ce poste

Flexible Time Off

11 paid holidays

Résumé du poste

Bristol Myers Squibb in Bothell, WA is seeking a Sr. Engineer, IT Compliance to lead cross-functional compliance activities for GxP electronic systems and applications. This role is primarily an individual contributor but may manage contract resources as needed.

You will partner with Quality, Business Owners and Technical Owners to ensure regulatory and procedural compliance across the system lifecycle, supporting the site's right to operate and continuous improvement.

Qualifications

• 2+ years direct experience with Quality Systems (Deviations, CAPAs, Change Requests, SOPs) and data integrity.
• Knowledge of global Health Authority regulations for computerized systems and electronic signatures.
• Strong documentation and metrics reporting for Quality Systems.

Responsabilités

• Manage IT metrics reporting related to regulatory compliance and Quality Events.
• Lead investigations and root cause analyses for IT Quality Event deviations.
• Author/review Quality Systems records (Deviations, CAPAs, Change Requests, SOPs).
• Collaborate with Quality, and Business/Technical Owners on continuous improvement to reduce adverse trends.
• Review applicable SOPs periodically.
• Participate in governance boards as IT representative for regulatory compliance.
• Support regulatory inspections as SME.
• Manage contract resources as needed.
• Assist with site integration and enterprise harmonization activities.

Connaissances

Quality Systems

Regulatory knowledge

Data integrity (ALCOA+)

Computerized systems experience

Formation

Bachelor's degree in life sciences/engineering/tech

5+ years biotech/pharma experience

Outils

MES

ERP

LIMS

QMS

Learning Management System

Description du poste

Bristol Myers Squibb in Bothell, WA is seeking a Sr. Engineer, IT Compliance to lead cross-functional compliance activities for GxP electronic systems and applications. This role is primarily an individual contributor but may manage contract resources as needed.

You will partner with Quality, Business Owners and Technical Owners to ensure regulatory and procedural compliance across the system lifecycle, supporting the site's right to operate and continuous improvement.