Director of Quality Assurance - USDA Biologics

6 days ago Be among the first 25 applicants

This range is provided by Akston. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$90,000.00/yr - $/yr

Direct message the job poster from Akston

Akston Biosciences has an immediate opening for a Director of Quality Assurance – USDA Biologics Manufacturing Facility in Shreveport, LA

Title Director of Quality Assurance USDA Biologics

Company

Akston is a biotech company built for pets. Using our proprietary Ambifect Fc-fusion protein platform, we develop immuno-enhancing and targeted protein treatments that aim to reduce treatment frequency while enhancing efficacy. Backed by a vertically integrated structure and state-of-the-art biologics facility, we accelerate development from discovery to commercial manufacturing – ensuring innovation reaches veterinarians and the pets we love, faster and more efficiently.

Learn more at

Position Summary

We are seeking a dynamic and experienced Director of Quality Assurance (QA) to lead and manage the Quality Assurance functions at our USDA-regulated biologics manufacturing facility located in Shreveport, LA. Reporting to the VP of Quality Assurance & Regulatory Affairs, this individual is responsible for ensuring all site operations are conducted in compliance with USDA Center for Veterinary Biologics (CVB) regulations, maintaining an inspection-ready state, and overseeing product release and serial disposition.

This is a critical leadership role requiring strong knowledge of USDA-CVB regulations, biologics manufacturing, and quality systems. The ideal candidate will have at least 5 years of experience in a QA leadership role within a USDA-regulated biologics or pharmaceutical environment.

Primary Duties

• Serve as the site Quality Unit Head per USDA-CVB requirements for the Shreveport facility
• Assist/lead the initial setup of the Quality Management System (QMS) for the Shreveport facility and lead the implementation and continuous improvement of the site’s QA in compliance with 9 CFR regulations and industry best practices
• Ensure regulatory compliance across all operations, including document control, change control, investigations, CAPA, deviation management, training, and internal audits
• Lead lot release activities, including review of batch records and test reports and disposition of serials.
• Oversee QA review and approval of standard operating procedures (SOPs), protocols, reports, specifications, manufacturing records, and analytical reports
• Maintain an inspection-ready state at all times and serve as the point of contact during USDA-CVB audits or regulatory inspections
• Ensure compliance with USDA requirements for raw material qualification and release, facility cleaning, equipment qualification, and environmental monitoring
• Collaborate with and assist the Director of Regulatory Affairs in the preparation and timely submission of regulatory filings and amendments
• Interface effectively with internal stakeholders, regulatory agencies, contract testing labs, and external partners

Other Responsibilities & Skills

• Apply analytical thinking and risk-based management to drive quality strategies
• Demonstrate strong writing skills, ensuring accuracy and strategic alignment
• Manage multiple projects and submissions, utilizing tools such as Microsoft Excel and Microsoft Project
• Work independently in a fast-paced environment, adapting to shifting priorities and deadlines while collaborating with cross-functional teams
• Make sound decisions under pressure and manage competing priorities
• Exhibit excellent communication and interpersonal skills to foster productive collaboration

Qualifications

• Bachelor’s or Master’s degree in Biological Sciences, Veterinary Medicine, or a related field
• Advanced training in the USDA regulatory framework and quality systems is highly desirable.

Experience

The successful candidate shall have:

• Minimum of 5 years of QA leadership experience (Director or Manager level) in veterinary biologics or pharmaceuticals regulated by USDA
• D…