Senior QA Manager: Regulatory Compliance & Client Audits

LifeScience Logistics LLC.; Brownsburg (IN); On-site; USD 95,000 - 135,000; Full time

Job summary

LifeScience Logistics LLC is seeking a Regulatory Compliance and Quality Leader to oversee FDA/cGMP, DEA, DSCSA compliance across 3PL operations. You will drive audits, CAPAs, and continuous improvement to ensure inspection readiness and client confidence.

This role requires 5+ years in pharma/regulated industries, supervisory experience, and strong data integrity controls in eQMS/LIMS. On-site Brownsburg, Indiana, with travel up to 15%.

Qualifications

• Minimum 5 years in quality/compliance in pharma, medical device, or FDA-regulated industries.
• Experience leading regulatory inspections and client audits.

Responsibilities

• Oversee regulatory compliance with FDA, cGMP, DEA, DSCSA and state licensing.
• Maintain inspection readiness for audits and client reviews.
• Lead and support regulatory inspections and client audits; respond to observations.
• Support internal audits and supplier qualification activities.
• Coach QA professionals and develop a high-performing team.

Skills

Quality leadership

Regulatory compliance

Audits & inspections

Data integrity & analytics

Education

Bachelor's degree in Biology, Chemistry, Engineering

Tools

eQMS

LIMS

Tecsys Elite

WebCTRL

Job description

LifeScience Logistics LLC is seeking a Regulatory Compliance and Quality Leader to oversee FDA/cGMP, DEA, DSCSA compliance across 3PL operations. You will drive audits, CAPAs, and continuous improvement to ensure inspection readiness and client confidence.

This role requires 5+ years in pharma/regulated industries, supervisory experience, and strong data integrity controls in eQMS/LIMS. On-site Brownsburg, Indiana, with travel up to 15%.