Associate Director Clinical Laboratory Services

Job DetailExperience Level Associate DirectorDegree Type Doctor of Philosophy (PhD)Employment Full TimeWorking Type On SiteJob Reference 0000020540Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful clinical laboratory operations ensuring regulatory compliance and innovation. Drive advancements in laboratory services with global oversight responsibilities. Collaborate with experts to enhance laboratory practices and technologies.Job DescriptionAssociate Director Clinical Laboratory Services OverviewThe 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 & DutiesProvide 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 RequirementsDoctoral 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.