Senior QA Lab Operations Lead—Regulatory Compliance

Foundation Medicine; Clegg (NC); On-site; USD 103,000 - 120,000; Full time

Job summary

Foundation Medicine in Morrisville, NC is seeking a Senior Specialist, Quality Assurance Laboratory Operations to oversee QA activities under CLIA, CAP, and FDA guidelines, driving process improvements and maintaining compliance. The role supports the Quality Management System, reviews documentation, coordinates audits, and collaborates across functions to implement regulatory-ready processes.

A science degree and 0–3 years in patient-testing QA are preferred; certifications are a plus.

Qualifications

• 0-3 years of prior experience with patient testing laboratory quality.
• Bachelor's degree in Science.
• Alternatively, an Associate's degree in laboratory science or related field with 5+ years of experience in clinical laboratory

Responsibilities

• Maintain QA system to ensure CLIA/CAP/FDA compliance.
• Review and approve information to FMI standards and procedures.
• Coordinate audits and respond to findings.
• Provide training on GxP guidelines.
• Lead or support inspections and regulatory audits.

Skills

Regulatory compliance

GxP knowledge

Quality Assurance

Education

Bachelor's degree in Science

Associate's degree in laboratory science

Tools

MasterControl

LIMS

Smartsheet

Maximo

Job description

Foundation Medicine in Morrisville, NC is seeking a Senior Specialist, Quality Assurance Laboratory Operations to oversee QA activities under CLIA, CAP, and FDA guidelines, driving process improvements and maintaining compliance. The role supports the Quality Management System, reviews documentation, coordinates audits, and collaborates across functions to implement regulatory-ready processes.

A science degree and 0–3 years in patient-testing QA are preferred; certifications are a plus.