Executive Director, Aseptic & Sterility Programs

Bristol Myers Squibb EU Policy; New Brunswick (NJ); On-site; USD 219,000 - 265,000; Full time

Benefits offered by this job

Flexible Time Off (FTO)

11 paid company holidays

Wellbeing and retirement benefits

Stock options

Job summary

Bristol Myers Squibb in New Brunswick, NJ seeks an enterprise-level leader for sterility assurance and microbial control, responsible for governance, policy, and cross-site harmonization. You will drive regulatory readiness, oversee CMO relationships, and ensure continuous improvement across sterile and non-sterile operations. The role requires deep expertise in microbiology, compliance, and global regulatory expectations.

Qualifications

• 15+ years in the pharmaceutical industry focusing on microbiology, sterility assurance, contamination control, or aseptic processing
• 8–10+ years in senior leadership with enterprise-level accountability for quality or regulatory strategy
• Experience across multiple manufacturing modalities (small molecule, biologics, cell or gene therapies)
• Strong understanding of global regulatory frameworks (FDA, EMA, ICH, USP) and experience with inspections

Responsibilities

• Govern aseptic operations, environmental monitoring, and microbial control programs enterprise-wide
• Lead Quality Council and EAC activities for sterility assurance and risk management
• Define thresholds for escalation of contamination events and systemic risks
• Establish enterprise-wide policies, standards, and procedures for aseptic control
• Set strategy and roadmaps for sterility assurance across sites
• Develop KPIs and monitoring to measure program effectiveness and compliance
• Lead trend detection, signal monitoring, and root-cause analyses across sites
• Provide guidance for regulatory inspections and technology transfers

Skills

Executive leadership

Quality governance

Sterility expertise

Regulatory knowledge

Data-driven decisions

Education

Bachelor's degree in Microbiology/related sciences

Job description

Bristol Myers Squibb in New Brunswick, NJ seeks an enterprise-level leader for sterility assurance and microbial control, responsible for governance, policy, and cross-site harmonization. You will drive regulatory readiness, oversee CMO relationships, and ensure continuous improvement across sterile and non-sterile operations. The role requires deep expertise in microbiology, compliance, and global regulatory expectations.