Associate Director, Environmental Monitoring Program Coordination

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.

This is work that transforms the lives of patients, and the careers of those who do it.

Establish and lead the global governance model for Environmental Monitoring across a network of biologics and cell therapy manufacturing sites, including internal sites, partner sites, and external manufacturing organizations as applicable.

Define harmonized EM program standards, procedures, sampling strategy expectations, monitoring frequencies, alert/action limit principles, escalation pathways, data review requirements, and periodic review processes across the manufacturing network.

Lead network-level EM data trending and governance, including comparison of site trends, identification of recurring or systemic adverse signals, evaluation of seasonal or geographic variability, and assessment of cross-site contamination control risks.

Develop and maintain a consistent global approach for EM trend evaluation, adverse trend definition, excursion categorization, impact assessment, mitigation planning, CAPA linkage, and effectiveness monitoring.

Translate local and network-level EM signals into actionable risk assessments, mitigation plans, contamination control improvements, and governance decisions in partnership with site Quality, Manufacturing, MS&T, Engineering, Facilities, Validation, and Sterility Assurance teams.

Coordinate cross-site response to significant or recurring EM excursions, including alignment on containment recommendations, investigation strategy, product quality impact considerations, root cause expectations, mitigation ownership, and effectiveness verification.

Serve as the global subject matter expert for environmental monitoring during deviation investigations, contamination events, aseptic process simulations, facility start-up, process transfers, new product introductions, campaign readiness, network governance reviews, and regulatory inspections.

Ensure site EM programs are aligned with the global Contamination Control Strategy, aseptic processing expectations, facility qualification state, cleaning and disinfection strategy, personnel gowning controls, manufacturing process risk assessments, and applicable health authority expectations.

Partner with manufacturing sites to evaluate environmental signals in relation to operational behaviors, material and personnel flows, interventions, cleaning practices, HVAC performance, facility maintenance, process design, and site‑specific operating models.

Lead global governance forums such as EM trend review boards, contamination control councils, site escalation meetings, network health reviews, and cross‑site mitigation forums for significant or recurring environmental monitoring signals.

Establish global metrics and dashboards to monitor EM program health across the network, including sample completion, excursion rates, adverse trend closure, investigation timeliness, CAPA effectiveness, alert/action frequency, recurrence, and inspection readiness indicators.

Support regulatory inspections and internal audits by presenting the global EM program structure, network governance model, data trend strategy, site‑to‑site consistency, excursion management approach, mitigation rationale, and continuous improvement actions in a clear and scientifically defensible manner.

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