Senior Biomarker & Diagnostics Quality Lead

Magnit Global; California (MO); On-site; USD 140,000 - 180,000; Full time

Job summary

BeOne is seeking a Senior Consultant for Clinical Biomarker & Diagnostics Quality to support the U.S. Biomarker Laboratory in San Carlos.

This hands-on, full-time role involves GCLP-aligned quality review, approval, qualification, validation, and implementation of laboratory equipment, software, and analytical methods across the development pipeline. The consultant will ensure data integrity, traceability, and inspection-ready documentation, and may support IC/IVD activities in later phases as

Qualifications

• Provide dedicated R&D Quality guidance for San Carlos Biomarker Laboratory.
• Review and approve GCLP or clinically relevant biomarker testing documentation.
• Ensure personnel qualification, training, materials, sample handling, and data integrity are compliant.

Responsibilities

• Provide quality oversight for laboratory qualification, validation, and documentation across equipment, software, and methods.
• Lead independent quality reviews of qualification/validation docs and risk assessments.
• Ensure traceability from sample receipt to data reporting and archival.

Skills

GCLP expertise

Clinical biomarker quality

Documentation & traceability

CAPA & investigations

GxP quality oversight

Tools

BIOVIA ELN

CISPro

Job description

BeOne is seeking a Senior Consultant for Clinical Biomarker & Diagnostics Quality to support the U.S. Biomarker Laboratory in San Carlos.

This hands-on, full-time role involves GCLP-aligned quality review, approval, qualification, validation, and implementation of laboratory equipment, software, and analytical methods across the development pipeline. The consultant will ensure data integrity, traceability, and inspection-ready documentation, and may support IC/IVD activities in later phases as