Senior Manager, Lab Operations (Clinical Safety Lab + PK lab)- On Site San Antonio TX- ICON
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
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.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply
