Job Description

Director, GLP Quality Assurance & Compliance

Shape the Future of Quality & Compliance in Preclinical Research

Are you a seasoned GLP Quality Leader looking to build something from the ground up? Join a pioneering in vivo research organization at the forefront of translational medicine, where your expertise in GLP compliance and quality assurance will drive excellence in preclinical studies. We are seeking a Director, GLP Quality Assurance & Compliance to establish and lead our Quality Assurance Unit (QAU) and ensure full compliance with regulatory standards.

Why Join Us?

• Be part of a cutting-edge research facility dedicated to advancing preclinical science.
• Lead the development of a GLP-compliant QAU from a fresh, bare facility to full compliance.
• Work on Surgical, PK, Cardiovascular, Bioanalysis, Anatomic Pathology, and Histology studies.
• Implement and transition from a paper-based QA system to Pristima or Provantis.
• Play a critical role in AALAC inspections and ensure compliance with FDA, USDA, AALAC, and 21CFR Part 11 standards.

Your Role:

As the Director of GLP Quality Assurance & Compliance , you will:

• Build & Lead the Quality Assurance Unit (QAU): Establish SOPs, policies, and a structured audit program to ensure GLP adherence across preclinical in vivo and in vitro studies.
• Ensure Regulatory & Data Integrity Compliance: Maintain 21CFR Part 11-compliant electronic records, oversee inspections, and drive Corrective and Preventative Actions (CAPAs).
• Oversee In Vivo & In Vitro Research Operations: Implement quality oversight for surgical and research procedures, ensuring proper sterility controls, aseptic documentation, and adherence to GLP principles.
• Train & Develop Junior Staff: Educate personnel on GLP fundamentals, such as certified feed requirements for primates and ensuring equipment calibration and controls for qPCR biodistribution studies.
• Serve as the Regulatory Compliance Leader: Act as the primary liaison for FDA, USDA, and external auditors, ensuring ongoing inspection readiness.

What You Bring:

• Bachelor’s degree in a scientific discipline (Biology, Pharmacology, Chemistry, Veterinary Sciences, etc.); PhD preferred but not required.
• 8+ years of GLP-regulated experience in preclinical research, CRO, or biopharmaceutical settings.
• 4+ years in GLP quality assurance, with experience building and leading a QAU.
• 2+ years of managerial experience in quality assurance or regulatory compliance.
• Expertise in GLP compliance, 21CFR Part 11, and electronic data integrity.
• Strong leadership, analytical, and problem-solving skills to implement and sustain best-in-class compliance programs.

What We Offer:

• Competitive compensation and benefits package.
• The opportunity to design and lead a GLP-compliant quality program from the ground up.
• A collaborative, innovative work environment dedicated to scientific excellence.
• Ongoing professional development and training to enhance your expertise.

Join Us!

If you're ready to make an impact by ensuring regulatory excellence and quality compliance in preclinical research, we want to hear from you! Apply today and take the next step in your career as a Director, GLP Quality Assurance & Compliance.

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