Global Validation/Verification coordinator
Core
Coordinates the implementation of new or updated laboratory tests in compliance with regulatory requirements and quality standards, overseeing validation/verification activities and documentation.
Role type
Senior IC validation/verification coordinator
Builds
Validated and verified laboratory test methods for global implementation
Domain
Clinical diagnostics and laboratory services
Required skills
Clinical laboratory method validation/verification, statistical software (EP Evaluator), hematology, clinical chemistry, serology, flow cytometry, molecular biology, report writing, milestone tracking, stakeholder alignment, documentation management
Preferred skills
Team lead experience, familiarity with EP Evaluator
Technologies
EP Evaluator
Responsibilities
Coordinate global validation or verification of laboratory tests, align with operational teams and laboratories on required activities and documentation, define and track validation/verification milestones with relevant stakeholders, ensure compliance with global validation and verification standards, complete, review, and approve all documentation including final signed validation/verification reports
Seniority
Senior, hands-on IC