Quality Lead — Warehouse QC & DEA Compliance

Uniphar Group; North Carolina; On-site; USD 63,000 - 77,000; Full time

Benefits offered by this job

Bonus eligibility

Comprehensive benefits

Collaborative work environment

Job summary

Uniphar seeks a Quality Lead to provide day‑to‑day quality leadership for warehouse and distribution activities. You will supervise the QC team, manage regulatory compliance, and oversee controlled substance inventory in line with GDP, GDP/GDocP, and QMS requirements.

Reporting to the US Head of Quality, you will ensure product handling, documentation, and release activities meet SOPs and regulatory expectations, driving continuous improvement and inspection readiness.

Qualifications

• Seven (7)+ years in a regulated life‑sciences role.
• Experience with cGMP and recordkeeping related to controlled substances.
• Proven experience with FDA 21 CFR Part 11 systems including validation and audit trails.
• Experience with ISO 134865:2016.

Responsibilities

• QC Team Leadership and Supervision: supervise, direct, prioritize, and coordinate QC activities.
• Warehouse Quality and Operational Compliance Oversight: monitor activities to ensure SOP, regulatory compliance and documentation.
• DEA and Controlled Substance Inventory Management: oversee DEA‑regulated distribution and records.
• Quality Management System Responsibilities: ensure QMS compliance, deviations, CAPAs, and change controls.
• Training and Compliance: reinforce SOPs and regulatory training across teams.
• Metrics, Trending, and Continuous Improvement: track quality metrics and drive improvements.
• Quality Authority: exercise authority to intervene, place holds, and escalate as needed.

Skills

Quality leadership

Regulated life sciences

FDA 21 CFR Part 11

Controlled substances compliance

Risk management

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Job description

Uniphar seeks a Quality Lead to provide day‑to‑day quality leadership for warehouse and distribution activities. You will supervise the QC team, manage regulatory compliance, and oversee controlled substance inventory in line with GDP, GDP/GDocP, and QMS requirements.

Reporting to the US Head of Quality, you will ensure product handling, documentation, and release activities meet SOPs and regulatory expectations, driving continuous improvement and inspection readiness.