Global Validation/Verification coordinator

The Validation/Verification Coordinator coordinates the implementation of (new or updated) laboratory tests in compliance with applicable regulatory requirements and quality standards. Coordinates and oversees test validation and verification activities, associated documentation, and QA and CAP Director reviews to ensure timely report approval and support successful test implementation.

Key Accountabilities

• 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.

Education

• Master's degree in Biochemistry/Life Sciences, or a bachelor’s degree with relevant experience.

Experience

• Minimum of 5-10 years of (medical) clinical laboratory experience, including at least 1-2 years of experience writing clinical laboratory validation/verification reports.
• Exeperience in hematology, clinical chemistry and serology, flow cytrometry and molecular biology
• Prior hands-on experience in method verification/validation is required.
• Working knowledge of EP Evaluator or similar statistical software for clinical laboratory validation/verification is required; familiarity with EP Evaluator specifically is preferred.

Abilities and/or Skills:

• Honest, Dependable, Demonstrated Ability to Self-Manage
• Detail Oriented, Accurate, Precise
• Strong Math Skills
• Strong Organizational Skills
• Logical Thinking, Good Reasoning Ability
• Strong communication including verbal, writing, and presentation skills
• Dedication to quality, ethics, and customer service
• Ability to handle personal stress
• Mental and emotional stability and maturity
• Motivation to excel
• Should be able to sit for long periods as per role requirement
• Team Lead experience