Associate Director Clinical Laboratory Services

Associate Director Clinical Laboratory Services Overview

• The Associate Director Clinical Laboratory Services provides leadership for global laboratory services and products under the guidance of the Global Clinical Laboratory Director.
• Oversees safety laboratory operations ensuring compliance with applicable regulations and standards for clinical excellence.
• Ensures technical staff qualifications, training, and competency meet regulatory and operational requirements.
• Leads the development, validation, and maintenance of laboratory tests tailored to client needs.
• Acts as a subject matter expert for client interactions and business development activities.
• Maintains inspection readiness by overseeing laboratory documentation and regulatory compliance.
• Promotes continuous improvement of laboratory SOPs and quality management systems.
• Collaborates with IT and leadership teams to optimize Laboratory Information Management Systems (LIMS).
• Ensures a safe and compliant laboratory environment for personnel and public health.

Associate Director Clinical Laboratory Services Key Responsibilities & Duties

• Provide scientific direction and oversight for North American Central Safety and Cellular Laboratories.
• Ensure global standardized processes for laboratory operations are implemented and adhered to.
• Monitor laboratory work to ensure reliable data generation and efficient reporting.
• Advise clients on laboratory findings and ensure accurate test result reporting.
• Lead regulatory interactions and maintain compliance with FDA, CLIA, CAP, EMA, and ISO standards.
• Develop and improve laboratory SOPs, GLPs, and quality assurance programs.
• Conduct quality audits and implement corrective actions for non-conformances.
• Manage personnel policies, competency assessments, and continuing education programs.
• Collaborate with IT teams to enhance laboratory information systems and workflows.

Associate Director Clinical Laboratory Services Job Requirements

• Doctoral degree (PhD) in clinical laboratory science, chemical, physical, or biological sciences.
• Minimum of 5 years’ experience as a clinical laboratory leader across multiple disciplines.
• Certification by relevant boards such as ABP, ABB, ABMM, ABCC, ABFT, ABMLI, or ABIM.
• Expertise in laboratory quality management systems and regulatory compliance.
• Proficiency in laboratory data acquisition technology and complex document analysis.
• Strong leadership and organizational skills with ability to manage and engage teams.
• Experience in laboratory test design, validation, and maintenance for clinical applications.
• Knowledge of proficiency testing programs and corrective action implementation.
• Commitment to promoting a safe and compliant laboratory environment.