Senior Manager, Laboratory Operations(Clinical Safety + PK Lab)
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
What You Will Do: Your focus will be on overseeing clinical laboratory operations delivery, maintaining regulatory compliance, and driving continuous improvement.
Key responsibilities include:
- 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.
Your Profile: You possess extensive knowledge of clinical laboratory operations, testing methodologies, specimen handling and processing requirements, and laboratory quality systems. You are able to provide technical leadership, sound judgment, and data-driven decision-making to support efficient and compliant laboratory operations. You have a proven track record of leading laboratory teams, optimizing workflows, managing resources, and maintaining regulatory compliance within a clinical research, pharmaceutical, or healthcare environment. You are passionate about delivering high-quality results while fostering a culture of accountability, collaboration, and continuous improvement.
Required qualifications and experience:
- 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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply