Critical Environments Director

• Support business development and growth of GMP Regulated Services business units and Critical Environments
• Support multiple projects concurrently using operations experience focused on GMP compliance and process excellence
• Apply industry best-known methods, Lean Six Sigma methodologies, and improvement tools
• Manage and coordinate services and projects
• Provide technical mentoring to department personnel
• Coordinate GMP Regulated service initiatives with functional area leaders
• Provide data for budgets and help manage multiple cost centers while ensuring compliance
• Complete performance appraisals for direct reports and review staff appraisals
• Create, develop, update, revise, and maintain documentation, policies, programs, procedures, and files
• Ensure compliance with service/project-related regulatory requirements
• Evaluate, select, and implement business solutions and process improvements
• Develop processes, services, and tools to improve efficiency and control costs
• Maintain accurate business documents in accordance with policies and regulations
• Develop or revise task instructions and operational procedures
• Provide updates to appropriate personnel
• Assist with or lead new service introductions and account transitions
• Interact with functional representatives during business-solution selection and implementation
• Communicate business-solution information to functional departments
• Support efficient manufacturing flow design using applicable state-of-the-art technology
• Provide support and training to service personnel and customers
• Implement special projects and assignments
• Coordinate staff travel to other facilities for meetings, service or technology transfers, improvement teams, and Critical Environment training
• Travel to support operational initiatives up to 50% of the time

• Bachelor’s degree in Business, Engineering, or related field from a four-year college or university, or equivalent combination of education and experience
• May be required to have a valid driver’s license
• Ability to perform essential duties safely and satisfactorily
• Ability to sit and talk or listen frequently
• Ability to lift and/or move up to 35 pounds
• Knowledge and ability required to manage critical-environment services and projects
• GMP compliance and regulatory-requirement knowledge
• Lean Six Sigma methodologies and tools
• Ability to develop and implement business solutions and process improvements
• Ability to create and maintain operational documentation and procedures
• Ability to travel up to 50% of the time and coordinate staff travel

Demonstrates expertise in GMP Compliance and Lean Six Sigma methodologies to drive process improvements and operational excellence. Capable of managing critical-environment services and projects while ensuring adherence to regulatory requirements and effective documentation practices.

• GMP Compliance
• Lean Six Sigma Methodologies
• Project Management
• Business Solutions Development
• Operational Documentation

• GMP Compliance
• Lean Six Sigma Methodologies
• Project Management
• Business Solutions Development
• Operational Documentation
• Process Improvement
• Data Analysis
• Budget Management
• Performance Appraisal Critical Environment Services Management

• Technical Mentoring
• Communication
• Team Coordination
• Training
• Interpersonal Skills

• GMP Regulated Services
• Regulatory Requirements
• Process Excellence
• Operational Procedures
• Business Development
• Cost Control
• Service Initiatives
• Manufacturing Flow Design
• Documentation Management
• Staff Travel Coordination