Remote Quality Operations Manager — Clinical Lab

Labconnect,-LL; Johnson City (TN); Remote; USD 120,000 - 160,000; Full time

Job summary

Labconnect, LLC is seeking a Manager, Quality Operations for a fully remote role. You will oversee the Quality Management System, CAPA program, and audit readiness across central laboratory operations supporting clinical trials.

The role requires 4+ years in a central lab quality function, with leadership experience and a strong grasp of GCP, CLIA, CAP, and ICH guidelines. Remote collaboration with global teams is essential.

Qualifications

• Bachelor's degree in life sciences, medical technology, or related field.
• Minimum 4 years in a central lab or clinical trial lab, with at least 2 years in quality management.
• Professional certifications are optional.

Responsibilities

• Champion Quality initiatives aligned with CFRs, CLIA, CAP, GCP, ICH, FDA, EMA.
• Manage Quality Events through investigation, CAPA planning, and effectiveness monitoring.
• Coordinate audits and sponsor inspections; support internal audit readiness.
• Lead cross-functional teams and mentor Quality Event owners.
• Perform trend analysis and CAPA effectiveness across quality systems.
• Collaborate with lab operations, data management, and project teams to ensure data integrity.

Skills

Quality management

GCP knowledge

ICH guidelines

CAPA

Data integrity

Leadership

Training

Analytical skills

Education

Bachelor's degree in life sciences or related field

Tools

eQMS (Veeva)

eLMS

Document control

MS Office (Word, Excel, PowerPoint, Project)

Job description

Labconnect, LLC is seeking a Manager, Quality Operations for a fully remote role. You will oversee the Quality Management System, CAPA program, and audit readiness across central laboratory operations supporting clinical trials.

The role requires 4+ years in a central lab quality function, with leadership experience and a strong grasp of GCP, CLIA, CAP, and ICH guidelines. Remote collaboration with global teams is essential.