Director of Quality

The Corporate Quality Director – Labstat Group is responsible for leading and overseeing the Quality Assurance function and the Quality Management System (QMS) across Labstat’s laboratories, ensuring full compliance with OECD GLP principles, ISO/IEC 17025, 21 CFR Parts 210/211, 21 CFR Part 11, USDA requirements, and client‑specific standards.

This role combines strategic leadership with hands‑on engagement in laboratory operations, quality oversight, and continual improvement. The Corporate Quality Director ensures that all GLP and ISO activities, documentation, and reporting meet regulatory expectations, accreditation requirements, and industry best practices.

Purpose:

Mission:

Values:

Responsibilities

• Maintain GLP and ISO compliance across all Labstat laboratories and ensure proper documentation of quality practices, study conduct, and results
• Lead the development, implementation, and continual improvement of Labstat’s GLP- and ISO‑compliant Quality Management System
• Provide leadership, mentorship, and training to the Quality Assurance team and laboratory personnel on GLP and ISO regulations and best practices
• Conduct and oversee internal GLP and ISO audits and ensure preparedness for external regulatory, accreditation, and client inspections
• Develop and track Quality metrics and Key Performance Indicators (KPIs) to identify trends, risks, and opportunities for improvement
• Ensure proper administration and timely updates to the QMS, including SOPs, study protocols, and quality documentation
• Serve as the primary contact for external auditors, regulatory authorities, and accreditation bodies, coordinating site‑level laboratory managers and technical staff during inspections
• Provide hands‑on training on GLP and ISO principles, laboratory procedures, and data integrity requirements
• Identify and implement process improvements to reduce errors, enhance compliance, and maintain study and accreditation integrity
• Review technical and laboratory data, summarize findings, and elevate critical issues to executive leadership
• Promote a culture of compliance, scientific integrity, and continuous improvement across the GLP and ISO laboratory network

Education & Experience

• MS in Microbiology, Chemistry, or a related scientific field
• Minimum 10 years of experience in a GLP- and ISO‑regulated laboratory or quality environment
• At least 2 years in a commercial testing laboratory setting
• Strong written and verbal communication skills
• Hands‑on experience with laboratory audits, documentation, and regulatory inspections
• In‑depth knowledge of OECD GLP principles, ISO/IEC 17025, and applicable regulatory requirements
• Lean Six Sigma or process improvement experience preferred
• Professional certifications (ASQ, SQA) are a plus

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