Job Title:
Senior Manager, Laboratory Quality Control
Location:
Ireland, Dublin Hybrid: Office/Remote
About ICON plc:
We are a world-leading healthcare intelligence and clinical research organization. Our mission is to shape the future of clinical development by fostering an inclusive environment driving innovation and excellence.
Our Culture:
We believe in our 'Own It' culture driven by four key values: Accountability & Delivery, Collaboration, Partnership, and Integrity. These values bring us together as individuals and set us apart as an organization.
Key Responsibilities:
* Lead and manage the validation and verification of diagnostic tests, including new assays and instruments.
* Design, perform, and analyze 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.
* Evaluate all validation processes for compliance with regulatory requirements, industry standards, and internal quality guidelines.
* 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.
Requirements:
* Bachelor's degree in Clinical Laboratory Science, Biomedical Science, or a related field; advanced degree preferred.
* 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.
* 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.
Benefits:
At ICON, we offer very competitive salary packages and a range of health-related benefits to employees and their families. We strive to create a workplace free of discrimination and harassment, where everyone has equal opportunities for employment.