Global Director, Microbiology Quality & Sterility

Bristol-Myers Squibb Co; Princeton (NJ); Hybrid; USD 261,000 - 316,000; Full time

Benefits offered by this job

Competitive compensation package

Comprehensive benefits

Job summary

Bristol-Myers Squibb Co is seeking an Executive Director, Microbiology Quality Sterility Assurance to lead enterprise-wide sterility and contamination control strategies. You will partner with PD, MSAT, Quality, and external CMOs to embed aseptic principles across manufacturing networks and drive governance at the executive level.

This role requires 10+ years in sterility assurance, global regulatory exposure, and strong leadership to shape risk-based programs and continuous improvement.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 10+ years in aseptic or sterility assurance in regulated environments.
• Global regulatory inspection experience with FDA/EMA/HMA.

Responsibilities

• Define and govern enterprise-wide Contamination Control Strategy (CCS).
• Lead sterility assurance governance across internal and external manufacturing sites.
• Partner with PD, MSAT, Quality, and external CMOs to embed aseptic design.
• Drive KPI framework, escalation thresholds, and executive reporting.
• Oversee cross-site investigations, CAPA, and remediation efforts.
• Support regulatory interactions and inspections globally.

Skills

Strategic Leadership

Sterility Assurance Governance

Regulatory Compliance

People Leadership

Education

Bachelor's degree in Microbiology/Life Sciences

MS/PhD preferred

Job description

Bristol-Myers Squibb Co is seeking an Executive Director, Microbiology Quality Sterility Assurance to lead enterprise-wide sterility and contamination control strategies. You will partner with PD, MSAT, Quality, and external CMOs to embed aseptic principles across manufacturing networks and drive governance at the executive level.

This role requires 10+ years in sterility assurance, global regulatory exposure, and strong leadership to shape risk-based programs and continuous improvement.