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.