Associate Director, Environmental Monitoring Program Coordination
Core
Establish and lead global governance for environmental monitoring across a network of biologics and cell therapy manufacturing sites to ensure contamination control and product quality.
Role type
Senior IC program director (environmental monitoring)
Builds
Global EM governance model, harmonized standards, data trending systems, and risk mitigation plans for sterile biologics/cell therapy manufacturing
Domain
Biopharmaceutical manufacturing (biologics/cell therapy) + Environmental Monitoring
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global program governance, environmental monitoring principles, contamination control strategy, GMP compliance, risk assessment, data trending, CAPA management, regulatory inspection support, cross-functional leadership, technical writing
Preferred skills
Advanced degree in scientific discipline, experience with LIMS/MODA systems, network expansion support
Technologies
LIMS, MODA, electronic trending tools, dashboards
Responsibilities
Define harmonized EM program standards and procedures across the manufacturing network; Lead network-level EM data trending and governance; Translate EM signals into actionable risk assessments and mitigation plans; Coordinate cross-site response to EM excursions; Serve as global SME for deviation investigations and regulatory inspections; Establish global metrics and dashboards for program health; Provide leadership and technical guidance to global QC and cross-functional teams; Evaluate and implement global digital systems for EM data; Support network expansion and technology transfer activities; Maintain awareness of evolving global regulatory expectations
Seniority
Senior, hands-on IC with people leadership