Director of Quality

@ Direct Customer Solutions LLC

Overview

The Director of Quality & Regulatory Compliance at Direct Customer Solutions LLC is responsible for establishing a corporate Quality Assurance and Regulatory Compliance System. This role involves developing a team focused on client satisfaction and financial performance improvement for R&S Solutions and DCS, LLC.

Key Responsibilities

• Develop, implement and manage a comprehensive Quality Management System (QMS).
• Lead quality and compliance teams with strategic short-term and long-term planning.
• Design and document procedures for process control and improvement in line with FDA, cGMP, PDMA, DEA regulations.
• Implement metrics for monitoring system effectiveness and support improvement initiatives such as Kaizen and Six Sigma.
• Conduct root-cause analysis and oversee corrective action initiatives.
• Manage internal and external audits and serve as the company representative for regulatory agencies.
• Collaborate with Operations and Sales teams, monitor vendor performance, and ensure SOPs are current.
• Educate and train associates on quality systems and participate in senior leadership meetings.

Requirements & Competencies

Required qualifications include a BS/BA in Quality Assurance, 10+ years in the Pharmaceutical Industry, extensive experience with QA systems and regulatory compliance, and excellent communication and computer skills. ASQ certification and familiarity with statistical process control are highly desirable.

Work Environment & Additional Information

This full-time position involves both office and warehouse work, requiring occasional travel (up to 30%). Schedule is Monday through Friday during 2nd shift hours. R&S Solutions, LLC/ DCS, LLC is an equal opportunity employer.

Key skills/competency

Director of Quality & Regulatory Compliance, QMS, FDA, cGMP, Audit, Root-cause Analysis, Six Sigma, Process Control, Compliance, Leadership