Quality Excellence Director — Pharma Logistics

RXinsider LTD.; Libertyville (IL); On-site; USD 170,000 - 200,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D insurance

Paid time off + holidays

3% company contribution

Job summary

RXinsider LTD. is seeking a Director of Quality to own the QMS across all operations and drive continuous improvement. You will partner with fulfillment, operations, and technology teams to embed quality into daily decisions and logistics practices.

You will lead deviations, CAPA, change control, and supplier quality oversight while ensuring alignment with GDP, GMP, and FDA requirements. The role demands strategic leadership and hands‑on execution to elevate performance and customer satisfaction.

Qualifications

• Bachelor’s degree in pharmacy, life sciences, engineering, quality management, or related field.
• Minimum of 5 years of experience leading quality operations, process improvement, or QMS management.
• Strong knowledge of GDP, GMP, ISO 9001, and FDA regulatory requirements.
• Proven success in implementing and maintaining QMS and managing audits, CAPA, and continuous improvement programs.
• Excellent analytical, communication, and stakeholder management skills.
• Ability to manage multiple priorities and teams.

Responsibilities

• Foster a culture of accountability, compliance, and continuous improvement within the organization.
• Develop, implement, and maintain the Quality Management System (QMS) in alignment with GDP/GMP, FDA 21 CFR Part 210–211, ISO 9001, and other applicable standards.
• Oversee quality processes including deviation management, change control, CAPA, document control, and supplier quality oversight.
• Lead quality operations reviews, ensuring key metrics are visible, understood, and actioned across sites.
• Manage internal and external audits, including vendor qualification and regulatory inspections.
• Serve as the subject matter expert for GDP, GSP, ISO certification, and quality compliance across pharma logistics operations.
• Design and implement CQI initiatives that enhance storage and transport quality, data integrity, and operational performance.
• Conduct root cause analysis, risk assessments, and trend evaluations to drive corrective and preventive actions.
• Partner with fulfillment, operations, and compliance teams to integrate quality principles into business workflows and logistics practices.
• Track, analyze, and report key quality metrics and performance indicators to leadership.
• Drive digital enablement of quality operations, leveraging data analytics, dashboards, and automation tools to improve visibility and responsiveness.

Skills

Analytical thinking

Communication

Stakeholder management

Prioritization

Education

Bachelor’s degree in pharmacy, life sciences, engineering, quality management, or related field

Advanced degree or professional certification (ASQ CQE, CQA, ISO Lead Auditor)

Job description

RXinsider LTD. is seeking a Director of Quality to own the QMS across all operations and drive continuous improvement. You will partner with fulfillment, operations, and technology teams to embed quality into daily decisions and logistics practices.

You will lead deviations, CAPA, change control, and supplier quality oversight while ensuring alignment with GDP, GMP, and FDA requirements. The role demands strategic leadership and hands‑on execution to elevate performance and customer satisfaction.