Director of Quality Assurance, GLP QAU

Director, GLP Quality Assurance & Compliance

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

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.

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 21

CFR Part 11 standards. The organization 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 Facility 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.

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 21
  
  CFR 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

• Provide regulatory and quality oversight of in vivo preclinical studies, ensuring adherence to GLP regulations and animal welfare standards (USDA, OLAW, AALAC, IACUC).
• Implement QA/QC processes for research and surgical procedures, ensuring proper sterility controls, aseptic technique documentation, and procedural compliance.
• Work with veterinary and scientific staff to enhance procedural accuracy, maintain study integrity, and prevent deviations from protocols.
• Ensure all study personnel, veterinary teams, and surgical staff are trained on GLP principles, and ethical research conduct.
• Oversee the implementation of a data integrity program for preclinical research, including audit trails, validation procedures, and security measures for electronic records.

3. Regulatory Compliance & Risk Management

• Serve as the primary regulatory liaison for FDA, USDA, and external auditors, ensuring the facility is always inspection-ready.
• Maintain full separation and independence from study personnel, ensuring unbiased quality assurance and compliance verification.
• Identify and mitigate compliance risks, reporting critical quality issues to senior leadership and advising on remediation strategies.

4. Team Leadership, Training & Continuous Improvement

• Recruit, train, and develop a high-performing QAU team, including QA auditors and compliance specialists to support facility-wide GLP adherence.
• Implement internal training programs to foster a culture of quality awareness, ensuring all personnel understand GLP expectations and regulatory requirements.
• Collaborate with IT and software development teams to implement electronic systems that support GLP compliance and data security.
• Design and implement a paper based system to serve as the backbone for a future electronic system.
• Monitor emerging regulatory trends and…