Senior Manager, Laboratory Quality Control - Ireland, Dublin Hybrid: Office/Remote 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.
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership, and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point.
Key Responsibilities: Lead and manage the validation and verification of diagnostic tests, including new assays and instruments.Design, perform, and analyse Accuracy, Precision, Reference Range, AMR, and other standard validation/verification experiments.Manage the validation of complex and Lab Developed tests including modifications to existing tests.Work directly with Sponsors on Sponsor-specific validations and requirements.Ensure that all validation processes comply with regulatory requirements, industry standards, and internal quality guidelines while following and maintaining Global SOPs.Conduct regular assessments of validation practices to identify areas for improvement.Perform root cause analysis on quality issues and suggest corrective and preventive actions.Supervise and mentor a team of Global Validation Analysts.Provide training and support to team members on validation techniques and best practices.Foster a collaborative and high-performance work environment.Identify and implement training programs as necessary to ensure they receive training in supervisory skill development.Productively work with internal groups such as Regulatory Affairs, Medical Affairs, Clinical Research, Project Management, and/or Quality Assurance to ensure efficient operations across the organization.Work closely with cross-functional teams including Laboratory operations, Global Quality Control, and Regulatory Affairs.Liaise with global laboratories to coordinate validation activities and share best practices.Keep management informed of project status in relation to quality and timelines using the validations tracker.Independently provide additional medical communications writing and editing services as required.Stay current with changes in regulatory requirements and ensure that validation processes are updated accordingly.Prepare and present documentation for regulatory submissions and inspections in collaboration with Regulatory Affairs.Maintain accurate and thorough documentation of all validation activities.Prepare comprehensive reports for internal stakeholders and regulatory bodies.Exhibit excellent written and oral communication and presentation skills.Qualifications: Education: Bachelor's degree in Clinical Laboratory Science, Biomedical Science, or a related field; advanced degree preferred.Experience: Minimum of 10 years of experience in clinical laboratory testing, with at least 3 years in a management or leadership role focused on test validations.Skills: Strong knowledge of validation methodologies, quality assurance principles, and regulatory requirements (e.g., CAP, NYS, CLSI, FDA, ISO, CLIA).Excellent leadership and team management skills.Proficiency in data analysis and interpretation.Exceptional communication and interpersonal skills.Ability to work effectively in a global and cross-functional environment.Benefits of Working in ICON: Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages and a range of health-related benefits to employees and their families.
ICON is an equal opportunity and inclusive employer and 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.
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