QA Manager: Regulatory Compliance & Audit Readiness

LifeScience Logistics LLC.; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

LifeScience Logistics is seeking a seasoned QA leader to drive regulatory compliance and inspection readiness across 3PL operations. You will lead audits, manage CAPA and deviation handling, and ensure robust QMS, data integrity, and eQMS/LIMS governance.

Responsibilities include supervising QA staff, facilitating client inspections, and maintaining compliance with FDA, DEA, and DSCSA. Travel up to 15% may be required.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, or a related field (equivalent experience may be considered).
• Minimum of 5 years of quality experience in the pharmaceutical, medical device, or other FDA-regulated industry.
• Minimum of 3 years of supervisory experience.
• Working knowledge of state and federal laws and regulations governing warehousing and distribution of pharmaceuticals and medical devices, including FDA, DEA, PDMA, and DSCSA, with the ability to interpret and apply them.

Responsibilities

• Ensure compliance with FDA regulations, cGMP, DEA, DSCSA, applicable state licensing requirements, and client-specific quality requirements across all 3PL operations.
• Maintain a constant state of inspection readiness for internal, client, and regulatory audits.
• Lead and support regulatory inspections and client audits, ensuring timely, complete responses to observations and follow-through on commitments.
• Support the internal audit (self-inspection) program and supplier/vendor qualification activities.
• Oversee and continuously improve core QMS processes, including deviations, CAPA, change control, document control, and training.

Skills

Regulatory compliance

Audits

Quality systems

CAPA

Deviations

Data integrity

GxP systems

Education

Bachelor’s degree in Biology, Chemistry, Engineering, or related field

Tools

eQMS

LIMS

Tecsys Elite

WebCTRL

Outlook

Excel

Word

PowerPoint

Job description

LifeScience Logistics is seeking a seasoned QA leader to drive regulatory compliance and inspection readiness across 3PL operations. You will lead audits, manage CAPA and deviation handling, and ensure robust QMS, data integrity, and eQMS/LIMS governance.

Responsibilities include supervising QA staff, facilitating client inspections, and maintaining compliance with FDA, DEA, and DSCSA. Travel up to 15% may be required.