Director of Quality Assurance

Organization & Job Summary

We are hiring for a QA Director to join a nonclinical CRO working with both small and large animal models while working collaboratively with groups that span biotechnology research. We are in the process of expanding our capabilities by becoming GLP compliant to better serve our sponsor's needs. We aim to begin generating IND- and IDE-enabling data for novel cell, gene, and oncolytic therapies that oftentimes require co-labeling with drug delivery devices.

The Quality Assurance Unit Director plays a vital role in the overall operations of the facility, with a primary responsibility to lead and oversee the Quality Assurance Unit. This role reports directly to the acting Test Facility Manager and provides independent oversight of all aspects of nonclinical studies, particularly those being conducted under current Good Laboratory Practices (cGLP).

This role is expected to act as a thought partner, working with other leadership members to assure that operations in all departments run smoothly and maintain compliance with relevant regulations, including those originating from the FDA, the USDA, the NIH, or other regulatory bodies.

This leader fosters strong collaboration with both senior leadership and other facility staff, offers balanced & objective quality counsel, and has a proven track record of building or maintaining compliant Quality Assurance Units within research organizations.

Responsibilities

• Assuring leaders, study sponsors, and regulatory inspectors that facilities, personnel, practices and records are in compliance with all applicable regulations, ensuring a complete portfolio of cGLP policies, procedures, and work practices
• Providing strategic direction to leadership through goal alignment, proposing continuous improvement initiatives, and educating the organization on best-in-class practices
• Assume ownership of all documents and reports produced by the team.
• Analyze complex situations and effectively communicate situations/issues, along with potential recommendations, to various functional groups where there is no precedent
• Remain objective/autonomous in implementing the Quality Assurance Unit program, while at the same time taking ownership and proactively working with the rest of the team to achieve the desired quality objectives
• Ensure proper root cause analysis and strong Corrective and Preventative Actions (CAPAs) are implemented for non-compliance(s)
• Support investigational new drug applications and related correspondence from regulatory authorities
• Invest deeply in team development plans; serve as a coach and mentor to others
• Reviews final study reports to assure that the reports accurately describe the methods and standard operating procedures, the reported results accurately reflect the raw data of a nonclinical laboratory study and determines that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation
• Ensure that the Quality Assurance Unit, the records maintained by the Quality Assurance Unit, and the method of indexing such records are in writing and are maintained in accordance with the regulations
• Collaborates with internal departments on strategy and implementation of quality principles and regulatory requirements

Preferred Licenses, Certifications, Registrations, Education and Experience

• Terminal degree (DVM, PhD, MD) in pharmaceutical, biological, or chemical sciences
• RQAP-GLP credential

Required Licenses, Certifications, Registrations, Education, and Experience

• Bachelor's degree
• Required Experience: Five (5) years of cGLP quality assurance experience
• Two (2) years of managerial or supervisory experience