Director of Quality Assurance, GLP QAU

Job Description

Job Description

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

• 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 continuously refine QA/QC programs to maintain best-in-class compliance practices .

Qualifications

Education & Experience

• Bachelor’s degree in a scientific discipline (Biology, Pharmacology, Chemistry, Veterinary Sciences, etc.); advanced degree (DVM, PhD, MD) preferred.
• 8+ years of GLP-regulated experience in a preclinical research, contract research organization (CRO), or biopharmaceutical setting .
• 4+ years in GLP quality assurance , with a demonstrated ability to build and lead a QAU .
• 2+ years of managerial or supervisory experience in quality assurance, regulatory affairs, or compliance oversight.

Technical & Leadership Competencies

• Expertise in GLP compliance with a strong understanding of 21CFR Part 11, electronic records/data integrity, and regulatory expectations .
• Experience developing and implementing quality programs as well as daily execution for in vivo preclinical research, surgical procedures, and regulatory compliance .
• Strong analytical and problem-solving skills to assess complex compliance issues and recommend effective solutions.
• Exceptional communication, leadership, and cross-functional collaboration skills .
• Ability to thrive in a fast-paced, evolving research environment , balancing compliance demands with operational efficiency .

What We Offer

• A pivotal role in shaping GLP compliance and preclinical research quality at a cutting-edge research facility.
• Competitive compensation and benefits package .
• Professional development and training opportunities to enhance expertise in regulatory compliance and quality systems .
• A collaborative, innovative work environment dedicated to scientific excellence and ethical research .

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 .