Associate Director, Lab Operations

The Opportunity:

Reporting to the Director of Laboratory Operations, as the Associate Director, Laboratory Operations, you will provide leadership for laboratory operations within the Knoxville Laboratory and is responsible for overall operational performance, quality, compliance, staffing, and resource management across laboratory functions and shifts. You will lead Managers, Senior Managers, and operational support leaders to ensure the laboratory meets safety, quality, service, financial, and operational goals. You will work closely with the Director, Quality, Validation, Human Resources, Facilities, IT, and other business partners to support a safe, compliant, and efficient operation while preparing the laboratory for future growth.

The Role:

Strategic Execution & Performance Management

• Translate lab-wide goals into actionable plans for assigned departments; establish KPIs and lead performance reviews to ensure goal achievement.
• Monitor and manage Laboratory Operations Key Performance Indicators (KPIs).
• Implement course corrections to achieve goals and contribute to monthly operational reports and presentations.

Operational Excellence & Process Optimization

• Lead initiatives to improve lab efficiency, throughput, and quality, including infrastructure upgrades and system enhancements.
• Analyze operational data to identify trends, diagnose root causes, and implement corrective actions to improve lab performance.
• Manage day-to-day capacity and organizational capability to perform high-volume testing required for the release of plasma per customer specifications.

Regulatory Compliance & Quality Oversight

• Ensure adherence to FDA, CLIA, cGMP, and internal SOPs; maintain inspection readiness and lead corrective/preventive actions.
• Ensure laboratory operations comply with all relevant regulatory agencies (FDA, CLIA, GHA, etc.). Maintain an "inspection-ready" condition at all times, drive corrective/preventive actions (CAPA), and ensure staff are trained in current SOPs.

Leadership & Talent Development

• Leads and develops Managers, Senior Managers, and operational leaders.
• Oversees staffing plans, succession planning, leadership development, employee relations, and workforce planning to support current and future operational needs.

Financial & Capital Management

• Supports development of operating budgets, staffing plans, and resource requirements.
• Monitors financial performance and works with laboratory leadership to ensure resources are aligned with operational demands and business priorities.

Cross-Functional Collaboration

• Partners with Quality, Validation, Human Resources, Facilities, IT, Engineering, and other business partners to support laboratory operations, implement improvements, and address operational challenges.

Stakeholder Engagement & Industry Relations

• Serves as a key representative for laboratory operations.
• Builds effective working relationships with internal and external stakeholders and supports business continuity, benchmarking, customer service, and operational planning activities.

Safety & Facility Oversight

• Promote a culture of safety and compliance; ensure facility maintenance meets operational and regulatory standards.
• Maintain a clean, efficient, and safe work environment.
• Ensure strict adherence to Environmental Health and Safety (EHS), OSHA, and Standard Operating Procedures (SOPs).

Change Leadership & Innovation

• Leads major operational changes that affect laboratory functions, staffing, workflows, systems, or business processes.
• Supports implementation of new technologies, equipment, and operational improvements while ensuring organizational readiness and adoption.

Your Skills & Abilities:

• Bachelor’s degree in chemical, biological, or clinical laboratory science, or medical technology from an accredited institution required.
• Medical Technologist preferred.
• Minimum of 8 years of relevant laboratory experience, including at least 4 years of leadership experience in a laboratory, healthcare, manufacturing, pharmaceutical, biologics, or other regulated environment.
• Regulatory Knowledge: Demonstrated working knowledge of FDA regulations, including GMP, GLP, and CLIA standards.
• Financial Acumen: Experience monitoring departmental budgets and managing resource allocations.
• Leadership & Communication: Proven ability to manage, motivate, and develop supervisory teams. Strong written, verbal, and presentation skills to effectively communicate metrics and drive operational results.
• Problem Solving: Excellent critical reasoning and analytical skills to resolve recurring operational defects and manage shifting priorities under tight deadlines.

Key Leadership Competencies

• Strategic thinking
• Operational leadership
• Organizational effectiveness
• Change management
• Cross-functional collaboration
• Continuous improvement mindset
• Quality and Regulatory focus

Working Conditions:

• Ability to compute, analyze, and interpret operational data and statistical forecasts.
• Fast-paced environment with frequent interruptions.

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