About
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. Base pay range
$90,000.00/yr - $120,000.00/yr Direct message the job poster from Akston Director Human Resources Akston Biosciences
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 www.akstonbio.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 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 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 On-site
role based in
Shreveport, LA . Contact
Candidates shoulds send CV and cover letter to careers@akstonbio.com For more information, see www.akstonbio.com. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Biotechnology Referrals increase your chances of interviewing at Akston by 2x Inferred from the description for this job
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Work experience
- QA
- QA Manual Test
- General Project Management
Languages
- English
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