Associate Director/Director, Lab Operations

About This Role

This role involves managing laboratory staff across a large department or multiple related departments. The successful candidate will assist with the administration of laboratory testing in accordance with applicable regulations governing clinical laboratories. This position contributes to departmental strategy and drives the achievement of operational objectives for laboratory operations.

Responsibilities

• Lead and manage the daily activities of assigned laboratory work groups
• Plan, prioritize, assign, and oversee laboratory workload and projects
• Partner with leadership to establish performance standards and operational objectives
• Recruit, develop, coach, and manage laboratory staff
• Establish goals, objectives, and metrics to support operational performance
• Identify opportunities to improve operational efficiency, quality, and financial performance
• Participate in budget planning activities, including consumables, instrumentation, and resource requirements
• Act as an escalation point for operational, quality, safety, and supply chain challenges
• Ensure compliance with laboratory regulations, quality requirements, and safety standards
• Partner with Quality Assurance and EHS teams to implement operational and compliance improvements
• Drive CAPA closure, quality metrics, root cause investigations, and continuous improvement initiatives
• Support the development and maintenance of laboratory policies, procedures, and quality systems
• Oversee the implementation of new tests, equipment, technologies, and operational processes as required
• Foster a collaborative culture that promotes teamwork, knowledge sharing, and employee engagement

Requirements

• Bachelor's Degree or equivalent combination of education and experience
• Minimum 5+ years of relevant experience in laboratory operations, including more than 5 years working within a regulated environment and at least 5 years of line management experience
• Practical knowledge of leading and managing execution processes, projects, and tactics for a large external sponsor portfolio
• Regulatory knowledge and experience with GCLP/GxP requirements for vaccine and/or specialty laboratory clinical testing and assay lifecycle management
• Strong technical understanding of operations and methods, including study setup and cross-functional/system dependencies
• In-depth knowledge of clinical testing procedures and applicable laboratory testing regulations
• Ability to work cross-functionally to establish a new laboratory facility, including equipment and assay technology transfer and qualification
• Working knowledge of quality assurance and quality control principles and in-depth knowledge of company-specific program requirements