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Job Description & How to Apply Below
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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