Job Title:

National Quality Manager Job Location:

Hebron, Kentucky We have an exciting opportunity for a National Quality Manager for our AFR Team. The National Quality Manager to lead and oversee the Life Sciences and Healthcare (LSH) Quality Management System (QMS) across all operations within the United States. This role ensures full compliance with GxP (

Good Practices:

GDP, GMP, GSP, etc.) standards, regulatory requirements, and customer expectations. The ideal candidate will serve as a key quality interface between global HQ, regional stakeholders, regulatory authorities, and clients within the pharmaceutical, biotech, and medical device sectors.

Key Responsibilities:

• Maintain and continuously improve the local GxP-compliant Quality Management System (QMS) aligned with national and global standards and local regulatory requirements (e.g., FDA, EMA, WHO, MHRA).
• Ensure compliance with Good Distribution Practices (GDP) and other applicable quality standards throughout transportation, warehousing, and handling of temperature-sensitive and critical healthcare shipments.
• Lead preparation, execution, and follow-up of internal, external, and customer audits, including regulatory inspections.
• Monitor CAPA implementation, deviation handling, change control processes, and risk assessments.
• Conduct regular site inspections and quality reviews across branches and logistics hubs.
• Develop and implement GxP training programs for operational and warehouse teams.
• Promote a strong quality culture through education, mentoring, and leadership.
• Act as primary point of contact for pharma/healthcare customers regarding quality-related topics.
• Collaborate with cross-functional teams (Operations, Sales, Warehouse) to support customer onboarding and SOP development.
• Support tenders and RFPs with quality inputs and certifications.
• Track and analyze KPI trends, deviations, audit findings, and improvement projects.
• Prepare and present quality reports for senior leadership.
• Manage temperature mapping and qualification activities for cool rooms, freezers, and temperature-controlled warehouse areas.
• Develop and maintain mapping protocols, validation reports, SOPs, and compliance documentation in line with GDP and regulatory requirements.
• Oversee calibration and maintenance of temperature monitoring equipment and data loggers.
• Analyze mapping data, investigate temperature excursions, and implement CAPA actions.
• Ensure continuous environmental monitoring and cold chain integrity across warehouse operations.
• Coordinate with operations, engineering, vendors, and customers to support audits, inspections, and compliance activities.
• Conduct risk assessments related to temperature-controlled storage and transport conditions.
• Support staff training on temperature control procedures and quality standards.

Skills /

Requirements:

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