About the role
QASHVO001 | Onsite | Shreveport, LA
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 GMP 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 www.akston.com.
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
- Minimum of 5 years of QA leadership experience (Director or Manager level) in veterinary biologics or pharmaceuticals regulated by USDA
- Demonstrated experience in USDA-CVB-regulated biologics manufacturing and serial release processes
- In-depth understanding of 9 CFR, USDA-CVB guidance documents and memos, and relevant good manufacturing principles and testing requirements for biologics
- Knowledge of animal health regulatory frameworks and product licensure under USDA conditional and full license pathways
Compensation
Commensurate with skills and experience; eligibility for company benefit plans
Other
Contact
For more information, see www.akstonbio.com.
To Apply Now Candidates should send CV and cover letter to careers@akstonbio.com.
