Senior Facility Quality Systems Lead | GMP & AI-Driven Compliance

Regulatory Jobs; New Brunswick (NJ); On-site; USD 100,000 - 121,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Facility Quality Systems Specialist to own the facility QMS compliance across the GFO site network. You will drive the centralization of quality processes, manage training programs, audits, CAPA, and improve data integrity using Maximo and Power BI.

The role requires GMP/GxP knowledge, independent judgment, and collaboration with cross-functional teams to advance quality and operational excellence.

Qualifications

• Bachelor's degree required, or equivalent combination of education and relevant work experience.
• 4-5 years of experience in facilities, quality systems, or compliance in GMP/GxP environment with cross-site programs preferred.
• Familiarity with CMMS platforms (Maximo) or electronic document management systems is a plus.

Responsibilities

• Own procedural documentation (SOPs/WIs) for assigned quality-related procedures and ensure timely revisions.
• Lead deviations, non-conformances, CAPAs, and change controls across sites.
• Own quality metrics reporting and analysis to identify trends and guide leadership.
• Lead investigations with scoping, root-cause analysis, documentation, and follow-up actions.
• Own data integrity initiatives and quarterly Maximo data reviews.
• Oversee QA reporting tools and dashboards (e.g., Power BI) and SharePoint coordination.

Skills

Quality systems

GxP compliance

Auditing

CAPA management

Root-cause analysis

Training coordination

Cross-functional collaboration

Project leadership

Education

Bachelor's degree

Tools

Maximo CMMS

Power BI

SharePoint

Job description

Bristol Myers Squibb is seeking a Senior Facility Quality Systems Specialist to own the facility QMS compliance across the GFO site network. You will drive the centralization of quality processes, manage training programs, audits, CAPA, and improve data integrity using Maximo and Power BI.

The role requires GMP/GxP knowledge, independent judgment, and collaboration with cross-functional teams to advance quality and operational excellence.