Global Validation/Verification coordinator
Core
Coordinates global validation and verification of laboratory tests to ensure compliance with regulatory requirements and quality standards, overseeing documentation and QA reviews for successful test implementation.
Role type
Senior Validation/Verification Coordinator
Builds
Validated and verified laboratory test methods
Domain
Clinical diagnostics and laboratory services
Required skills
Method verification/validation, statistical software (EP Evaluator), regulatory compliance, milestone tracking, report writing, stakeholder alignment
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