Quality Operations Specialist

Quality Operations Specialist Pharma Logistics

Location : Libertyville, IL

Reports To : Head of Business Alignment Office

Job Summary :

The Quality Operations Specialist Pharma Logistics will own and manage the oversight of PLs quality management system (QMS) across all operations, ensuring it drives consistency, efficiency, and excellence in execution. This role provides both strategic and hands-on leadership, embedding quality principles into daily operations and decision-making. The Manager will champion continuous quality improvement (CQI) initiatives to enhance process reliability, product handling accuracy, and customer satisfaction. Serving as a key partner to fulfillment, operations, and technology teams, this leader ensures that quality is not just maintained but continuously optimized fostering a culture of performance, accountability, and operational excellence.

Job Duties & 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 210211, 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.
• Translate quality data and trends into executive insights, influencing decision-making and investment priorities.
• Serve as a champion for operational excellence, leading cross-functional projects that elevate performance, efficiency, and customer experience.

Required Qualifications :

Preferred Qualifications :

Equal employment opportunity, including veterans and individuals with disabilities.