Senior Manager, Laboratory Operations(Clinical Safety + PK Lab)

ICON plc • San Antonio, TX

5d • Onsite

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Senior Manager, Laboratory Operations at ICON, you will provide leadership for both our Clinical Safety Laboratory and Sample Processing Laboratory, ensuring the delivery of high-quality laboratory services in support of clinical research studies. You will be responsible for ensuring laboratory operations are conducted safely, accurately, efficiently, and in accordance with study protocols, regulatory requirements, and sponsor expectations. This role requires a hands-on leader who can effectively manage laboratory operations, drive continuous improvement, maintain inspection readiness, and foster a culture of quality and operational excellence. Location: 100% on site- San Antonio TX 78232

Requirements

• Bachelor's degree in a relevant scientific discipline or laboratory science.
• Minimum of 5 years of laboratory operations management experience, preferably within the clinical research, pharmaceutical, or biotechnology sectors.
• Demonstrated experience managing laboratory personnel, quality systems, and laboratory operations.
• Strong understanding of CLIA, COLA, FDA, GCP, and applicable regulatory requirements.
• Experience supporting audits, inspections, and quality improvement initiatives.
• Strong leadership and people-management skills, with experience developing and mentoring high-performing teams.
• Expertise in laboratory quality management systems and regulatory compliance.
• Excellent problem-solving and decision-making abilities.
• Strong organizational and project-management skills, with the ability to manage multiple priorities simultaneously.
• Effective communication and stakeholder-management skills.
• Experience leading change initiatives and driving operational improvements.
• A commitment to quality, safety, operational excellence, and customer service.

Responsibilities

• Provide oversight and management of day-to-day laboratory operations for both Clinical Safety and Sample Processing laboratories.
• Ensure compliance with CLIA, COLA, FDA, GCP, and sponsor requirements.
• Oversee laboratory quality systems, including quality control programs, proficiency testing, competency assessments, and staff training.
• Serve as a key contributor during protocol feasibility assessments, laboratory review activities, and study budget development.
• Partner closely with Clinical Operations, Investigators, Data Management, Sponsors, and other cross-functional stakeholders to support successful study execution.
• Manage laboratory staffing, workload forecasting, resource allocation, and scheduling to ensure operational efficiency and study support.
• Lead and support internal and external audits, sponsor inspections, and regulatory inspections, ensuring appropriate corrective and preventive actions (CAPAs) are implemented and monitored.
• Oversee laboratory equipment lifecycle management, including validation, qualification, calibration, preventive maintenance, and troubleshooting.
• Manage laboratory vendors and service providers, ensuring quality performance, cost effectiveness, and timely delivery of services.
• Provide leadership, guidance, and strategic oversight to the Sample Processing Laboratory Manager and laboratory staff.
• Identify and implement process improvements, leveraging emerging laboratory technologies and industry best practices to enhance operational performance.
• Ensure laboratory operations remain inspection-ready and aligned with evolving regulatory and industry standards.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Manager