Associate Director, Lab Operations - Growth & Compliance

BioSpace; Knoxville (TN); In loco; USD 180.000 - 230.000; Tempo pieno

Descrizione del lavoro

CSL Plasma is seeking an Associate Director, Laboratory Operations in Knoxville to lead laboratory operations, ensure safety and quality, and drive performance across shifts. You will manage leaders, develop staffing plans, and monitor KPIs to meet regulatory standards and business goals.

You will collaborate with Quality, Validation, HR, Facilities, IT, and Engineering to implement improvements, upgrade infrastructure, and prepare for growth while maintaining an inspection-ready operation.

Competenze

• Bachelor’s degree in a clinical laboratory science field is required.
• Minimum of 8 years of relevant lab experience with 4 years in leadership.
• Regulatory knowledge of FDA, GMP, GLP, and CLIA standards.

Mansioni

• Translate lab goals into actionable plans and KPIs.
• Monitor KPIs and drive performance reviews and course corrections.
• Lead initiatives to improve efficiency, throughput, and quality.
• Ensure compliance with FDA, CLIA, cGMP; maintain inspection readiness.
• Develop leaders, manage staffing plans, and support budget needs.
• Collaborate cross-functionally with Quality, HR, Facilities, IT, and Engineering.
• Oversee safety, CAPA actions, and continuous improvement.

Conoscenze

Leadership

Regulatory knowledge

Financial acumen

Communication

Problem solving

Strategic thinking

Operational leadership

Change management

Continuous improvement

Formazione

Bachelor’s degree in chemical, biological, or clinical laboratory science, or medical technology

Medical Technologist preferred

Descrizione del lavoro

CSL Plasma is seeking an Associate Director, Laboratory Operations in Knoxville to lead laboratory operations, ensure safety and quality, and drive performance across shifts. You will manage leaders, develop staffing plans, and monitor KPIs to meet regulatory standards and business goals.

You will collaborate with Quality, Validation, HR, Facilities, IT, and Engineering to implement improvements, upgrade infrastructure, and prepare for growth while maintaining an inspection-ready operation.