Director, US Laboratory Operations

The Director, US Laboratory Operations provides dedicated operational leadership for the Highland Heights laboratory operation and is accountable for the safe, compliant, reliable, and efficient execution of US laboratory testing. The role ensures consistent delivery of quality, turnaround time, productivity, capacity, and customer commitments while continuously improving laboratory performance and scalability.

The Director leads the US laboratory testing organization and associated operational support capabilities, including laboratory quality control and automation, and partners closely with Medical Directors and functional stakeholders. The role establishes the operating system, resource and capacity plans, and performance standards required to deliver high-quality clinical trial testing while advancing technology, automation, workforce capability, and continuous improvement.

• ◆Develop and execute the laboratory operating strategy aligned with GCL business priorities, customer commitments, scientific requirements, quality standards, and growth plans.
• ◆Own end-to-end operational performance for US laboratory testing, including safety, quality, turnaround time, productivity, capacity, schedule attainment, cost, and service delivery.
• ◆Establish and actively manage laboratory KPIs and operating mechanisms to identify performance gaps, accelerate issue resolution, and sustain continuous improvement.
• ◆Lead laboratory operations teams and associated operational support capabilities, including Lab QC and Automation, with clear accountability, standards, and performance expectations.
• ◆Partner with US Medical Directors and Scientific Affairs to ensure laboratory testing is scientifically appropriate, technically robust, harmonized where required, and aligned with protocol and customer commitments.
• ◆Ensure laboratory operations comply with applicable quality systems, regulatory and accreditation requirements, safety standards, SOPs, and client/study requirements; partner with Quality on deviations, CAPA, audit readiness, inspections, and regulatory responses.
• ◆Own laboratory capacity and resource planning, including staffing, scheduling, space, equipment, instrumentation, maintenance dependencies, and operational readiness to support current demand and future growth.
• ◆Own workforce planning, staffing, training, qualification, performance management, succession, and leadership development for the laboratory organization.
• ◆Partner with Sample Management & Site Services to define and continuously improve the testing-ready handoff, resolve cross-site flow constraints, and minimize downstream impact from sample-related issues.
• ◆Partner with Client Delivery and other customer-facing teams on significant laboratory performance issues, study risks, escalations, and corrective actions while ensuring timely and accurate operational communication.
• ◆Develop and manage operating budgets, forecasts, capital/resource requirements, and productivity plans; identify opportunities to improve cost efficiency while protecting quality and service.
• ◆Champion automation, technology, process innovation, and operating model improvements that increase laboratory capacity, reliability, efficiency, and scalability.
• ◆Recruit, develop, coach, and retain high-performing leaders and teams while fostering a culture of safety, quality, accountability, scientific rigor, innovation, and continuous improvement.

Key

• ✓Bachelor's degree or equivalent and relevant formal academic / vocational qualification in life sciences, laboratory science, or a related field
• ✓Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) including significant leadership experience in clinical laboratory operations, pharmaceutical/biotech laboratory services, diagnostics, or a comparable regulated environment. Experience leading large teams, operational transformation, and complex laboratory operations is strongly preferred.
• ✓5+ years of management responsibility
• ✓Strong leadership skills
• ✓Advanced degree preferred. CAP/CLIA accreditation, or willingness and capability to obtain applicable credentialing, is desirable where relevant to the role.