Director, US Laboratory Operations

Essential Functions and Responsibilities

• 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 Qualifications

Education and Experience: 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.

Knowledge, Skills, and Abilities

• Executive-level laboratory operations leadership and change management
• In-depth knowledge of clinical laboratory operations in pharmaceutical and biotech environments
• Quality systems, regulatory/accreditation compliance, and audit readiness
• Laboratory capacity, workforce, instrumentation, and resource planning
• Data-driven performance management and operational analytics
• Automation, technology deployment, and continuous improvement
• Budgeting, forecasting, capital planning, and financial acumen
• Cross-functional integration across science, quality, sample management, and client delivery
• Customer and study delivery orientation
• Talent development, coaching, and organizational capability building
• Executive communication, influencing, and stakeholder management
• Ability to lead effectively in a fast-paced, highly regulated environment