Manager Manufacturing Environmental and Contamination Control

Responsibilities

• Direct Management of Deviation Owners & FAO's
• Lead and coordinate:
• Deviation Owners (execution)
• Process Specialists (technical oversight)
• Ensure:
• Clear ownership assignment and appropriate planning and distribution of workload
• Timely movement of records
• Oversee:
• Initiation triage investigation closure
• Ensure records are complete, accurate, and audit-ready
• Remove barriers to timely closure and escalation
• Ensure:
• Robust root cause analysis (RCA)
• Appropriate scoping and impact assessment
• Challenge teams to avoid superficial or convenience-based conclusions
• Ensure microbial deviations receive appropriate SME engagement (QC Micro, aseptic SMEs)
• Verify:
• Investigations reflect true contamination risks
• Classification reflects risk (not bias or precedent)
• Facilitate alignment between:
• FAO
• QA
• Deviation Owner
• Ensure decisions (classification, disposition) are clearly documented
• Ensure CAPAs are:
• Assigned
• Owed
• Completed effectively
• Confirm clear linkage between root cause and actions
• Lead daily deviation triage for environmental and contamination control-related events
• Prioritize high-risk (e.g., microbial, major deviations)
• Ensure effective tools and business processes are in place for tracking and reporting record progress
• Allocate resources appropriately
• Prepare team to:
• Speak to deviations directly
• Defend scientific rationale
• Ensure records are inspection-ready at all times
• Create a culture of continuous improvement among the ECC team and facilitate implementation of tools and processes that streamline the investigation process, making appropriate use of AI and other digital tools.
• On-time closure (OTD)
• Aging backlog
• Investigation effectiveness
• CAPA cycle time
• Audit/inspection observations

Qualifications

• High school diploma/GED and 12 years of manufacturing or operations experience OR
• Associates degree and 10 years of manufacturing or operations experience OR
• Bachelor's degree and 5 years of manufacturing or operations experience OR
• Masters degree and 3 years of manufacturing or operations experience OR
• Doctorate degree
• In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above