Aseptic Operations Leader & Sterility Strategy

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

Job summary

Bristol Myers Squibb is seeking a Sr. Director of Aseptic Operational Support in New Jersey. This leadership role oversees sterility assurance, environmental monitoring, and contamination control across multiple manufacturing sites, including CMO oversight and strategic program governance.

The successful candidate will drive enterprise-wide quality initiatives, manage regulatory interactions, and lead cross-site teams to sustain scientific rigor and continuous improvement in aseptic processes.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline.
• 15+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing.
• Minimum 8–10 years in senior leadership roles with enterprise-level accountability for quality, compliance, or regulatory strategy.
• Deep experience working in manufacturing facilities across multiple modalities, including small molecule, biologics, cell therapy, or gene therapy.
• Demonstrated expertise in global regulatory frameworks (FDA 21 CFR Parts 210/211/600, EU GMP Annex 1, ICH Q9/Q10, USP, PIC/S, and others).
• Proven experience leading or supporting regulatory inspections (FDA PAI/GMP, EMA, MHRA, or equivalent).
• Track record of leading enterprise-wide harmonization and change management programs.

Responsibilities

• Govern enterprise aseptic and microbial control practices, including escalation pathways and structured decision frameworks.
• Provide executive-level leadership for Quality Council and EAC activities related to sterility assurance and contamination control.
• Define thresholds for escalation of contamination events and systemic risks across sites.
• Establish and own policies, standards, and procedures governing aseptic operations and environmental monitoring.
• Define the enterprise aseptic, microbial control, and sterility assurance roadmap with priorities and strategy.
• Establish KPIs and performance monitoring to measure program effectiveness and compliance.
• Lead cross-site harmonization of aseptic practices across the global manufacturing network.
• Champion knowledge management and a culture of continuous improvement.
• Serve as enterprise technical authority for sterility assurance and microbial control.

Skills

Enterprise thinking

Technical depth

Executive communication

Change leadership

Data fluency

Collaboration

Education

Bachelor's degree in Microbiology or related field

Job description

Bristol Myers Squibb is seeking a Sr. Director of Aseptic Operational Support in New Jersey. This leadership role oversees sterility assurance, environmental monitoring, and contamination control across multiple manufacturing sites, including CMO oversight and strategic program governance.

The successful candidate will drive enterprise-wide quality initiatives, manage regulatory interactions, and lead cross-site teams to sustain scientific rigor and continuous improvement in aseptic processes.