Global Environmental Monitoring Program Lead

Bristol Myers Squibb; Dublin; On-site; EUR 120,000 - 180,000; Full time

Job summary

Bristol Myers Squibb is seeking a senior Environmental Monitoring leader to establish and govern the global EM program across a biologics and cell therapy network. The role emphasizes harmonized standards, cross-site data trends, and risk-based decision making to ensure regulatory readiness and product quality.

You will drive CAPA integration, escalation pathways, and governance forums, partnering with Quality, Manufacturing, MS&T, Engineering, Facilities, Validation, and Sterility teams.

Qualifications

• Bachelor degree in a scientific discipline; advanced degree preferred.
• 10+ years biotech/biologics manufacturing with GMP experience.
• Experience establishing and governing EM programs across multiple sites.

Responsibilities

• Establish and lead global EM governance across biologics and cell therapy sites.
• Define harmonized EM program standards, sampling, monitoring and alert thresholds.
• Lead cross-site data trending, identify systemic risks, and assess cross-site contamination controls.
• Develop global EM trend evaluation, excursion categorization, CAPA linkage and effectiveness monitoring.
• Translate EM signals into risk assessments and mitigation plans with site stakeholders.
• Coordinate cross-site responses to EM excursions and regulatory readiness.
• Serve as global SME for EM during deviations, contamination events, and inspections.
• Ensure EM programs align with Contamination Control Strategy and aseptic processing expectations.
• Lead governance forums and establish global metrics and dashboards for EM health.

Skills

EM governance

Data trending

Cross-functional leadership

Regulatory inspections

cGMP knowledge

Scientific writing

Education

B.S. in Microbiology/Pharmaceutical Sciences

Advanced degree preferred

Tools

MODA/LIMS

Electronic trending tools

Job description

Bristol Myers Squibb is seeking a senior Environmental Monitoring leader to establish and govern the global EM program across a biologics and cell therapy network. The role emphasizes harmonized standards, cross-site data trends, and risk-based decision making to ensure regulatory readiness and product quality.

You will drive CAPA integration, escalation pathways, and governance forums, partnering with Quality, Manufacturing, MS&T, Engineering, Facilities, Validation, and Sterility teams.