Director of Quality Assurance, GLP QAU

Director, GLP Quality Assurance & Compliance

Building a Culture of Quality & Compliance in a Leading In Vivo Research Facility

Company Overview

We are a pioneering research organization dedicated to translational medicine , bridging the gap between research and real-world applications to improve human health. As we expand our in vivo research capabilities , including a variety of preclinical studies , we are seeking an experienced Director, GLP Quality Assurance & Compliance to establish and lead a Quality Assurance Unit (QAU) . This role will be critical in ensuring full Good Laboratory Practice (GLP) compliance and fostering a culture of quality across all research operations.

Position Overview

The Director, GLP Quality Assurance & Compliance will design, implement, and oversee a Quality Assurance Unit (QAU) that ensures research integrity and compliance with GLP regulations , FDA , USDA , AALAC and 21CFR Part 11 standards. The organiztion will start out on a paper based system and eventually move to a system like Pristima or Provantis. This role will be starting out from a fresh, bare facility and brought up to full compliance. Reporting to the Test Faciliyt Manager , this leader will develop policies, oversee audits, and guide the organization through regulatory inspections. Additionally, they will play a key role in supporting in vivo research protocols and procedures procedures , ensuring that all processes align with in vivo and in vitro GLP studies and animal welfare regulations .

Key Responsibilities

1. Establishing & Leading the Quality Assurance Unit (QAU)

• Develop and implement the Quality Assurance Unit (QAU) to provide independent oversight of nonclinical in vivo research and surgical studies .
• Establish robust SOPs, policies, and procedures to align the entire facility with GLP principles and regulatory best practices of an in vivo and in vitro preclinical testing facility .
• Design a structured audit program , including facility inspections, process reviews, data integrity assessments, and study audits to drive continuous improvement .
• Ensure that all study documentation, electronic records, and data management systems adhere to 21CFR Part 11 and GLP-compliant guidelines.
• Develop mechanisms for root cause analysis and Corrective and Preventative Actions (CAPAs) to address compliance gaps .

2. Quality Oversight of In Vivo and In Vitro Research Operations

3. Regulatory Compliance & Risk Management

4. Team Leadership, Training & Continuous Improvement

Qualifications

Education & Experience

Technical & Leadership Competencies

What We Offer

Join Us!

If you are an experienced GLP Quality Leader with a passion for building world-class quality programs and ensuring compliance in in vivo research non-clinical studies , we invite you to apply. Help us advance preclinical science while upholding the highest standards of quality, integrity, and regulatory excellence .