Quality Assurance Manager

Job overview

The Quality Assurance Manager role is onsite in Durham, NC, primarily in an office with regular time in warehouse and cleanroom areas as needed. Compensation is not specified. The role supports Life Science Logistics’ quality oversight across its third-party logistics operations. The role exists to maintain regulatory compliance and an effective quality management system while supporting safe, controlled handling of regulated products. It contributes to operational quality through audit readiness, investigation and corrective action, cleanroom oversight, client partnership, continuous improvement, and leadership of quality professionals.

What you'll do

• Maintain compliance with FDA, cGMP, DEA, DSCSA, state licensing, and client quality requirements
• lead and support inspections and audits
• oversee QMS processes including deviations, CAPA, change control, document control, training, complaints, returns, recalls, and temperature excursions
• ensure data integrity and electronic record compliance
• oversee cleanroom sampling and dispensing and environmental monitoring
• analyze quality metrics and report performance
• serve as primary quality contact for commercial clients
• lead, coach, and develop QA staff. Requires a bachelor’s degree in a related field or equivalent experience, at least five years of quality experience in a regulated industry, at least three years of supervisory experience, and travel up to 15%.

What we're looking for

Skills & competencies

quality assurance manager

durham nc

life science logistics

fda compliance

cgmp

dscsa

quality management system

capa

cleanroom

environmental monitoring

team leadership

travel up to 15%

Work arrangement

• Weekend coverage required

Why this role

Quality leadership spanning regulated logistics, cleanroom operations, environmental monitoring, and client audits.

About the employer

Life Science Logistics LLC is hiring for this role. Industry: Process, Physical Distribution, and Logistics Consulting Services. Sector: 54.