Director of Quality Assurance - USDA Biologics

Akston; Shreveport (LA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Disability insurance

Paid maternity leave

Job summary

A biotech company is seeking a Director of Quality Assurance for their USDA-regulated biologics manufacturing facility in Shreveport, LA. The role involves overseeing quality systems, ensuring compliance with USDA regulations, and leading a team to maintain an inspection-ready state. Applicants should have at least 5 years of experience in QA leadership within a USDA-regulated environment and a relevant degree. Competitive compensation and comprehensive benefits offered.

Qualifications

• Minimum of 5 years of QA leadership experience 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 and USDA-CVB guidance documents.

Responsibilities

• Lead and manage the Quality Assurance functions at the USDA-regulated biologics manufacturing facility.
• Ensure regulatory compliance across all operations, including document control and internal audits.
• Oversee QA review and approval of SOPs and manufacturing records.

Skills

Analytical thinking

Project management

Strong writing skills

Interpersonal communication

Education

Bachelor’s or Master’s degree in Biological Sciences, Veterinary Medicine, or a related field

Tools

Microsoft Excel

Microsoft Project

Job description

Director of Quality Assurance - USDA Biologics

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 [e-mail]

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

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Inferred from the description for this job

Medical insurance

Vision insurance

Disability insurance

Paid maternity leave

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