Head of Quality

Position Summary Director, Head of Quality to establish and lead all Quality Assurance (QA) and Quality Control (QC) activities for our pet-specific cell and gene therapy programs. Reporting directly to the CEO, this Director-level role will design and maintain a phase-appropriate, risk-based Quality Management System (QMS) that ensures full compliance with current Good Manufacturing Practices (cGMP) and applicable veterinary regulatory requirements. The ideal candidate will bring deep expertise in aseptic processing and sterile product manufacturing, combined with a pragmatic, risk-based approach suitable for both early clinical and late-stage commercial readiness. This is a critical leadership position that will shape quality culture and enable rapid, compliant advancement of our novel therapies for pets. Key Responsibilities Develop, implement, and continuously improve a phase-appropriate QMS tailored to cell and gene therapy manufacturing, applying risk-based principles (per ICH Q9 and FDA guidance) across process development, clinical supply, and commercial-scale production. Provide strategic and operational leadership for all QA/QC functions, including batch record review, product release, deviation investigations, CAPA management, change control, and stability programs. Oversee aseptic process validation, environmental monitoring, media fill programs, and sterility assurance for cell and viral-vector manufacturing in ISO-classified cleanrooms. Ensure timely and compliant support for regulatory submissions (e.g., FDA Center for Veterinary Medicine (CVM) Investigational New Animal Drug (INAD) applications and eventual New Animal Drug Applications (NADA)). Conduct and manage internal audits, supplier/CMO quality oversight, and preparation for regulatory inspections (FDA

CVM, USDA APHIS

if applicable). Collaborate cross-functionally with Manufacturing, Process Development, Regulatory Affairs, and Clinical teams to integrate quality into every stage of product lifecycle. Build, mentor, and lead a high-performing Quality team; establish quality metrics, training programs, and a culture of continuous improvement. Perform risk assessments and implement mitigation strategies for manufacturing, testing, and distribution activities. Stay current with evolving FDA CVM, USDA, and international guidelines specific to veterinary advanced therapies. Required Qualifications Education Bachelor's or Master's degree in a scientific discipline (Biology, Microbiology, Chemistry, Chemical Engineering, or related field) required. PhD is not necessary. Experience Minimum 8-10 years of progressive Quality experience in the biopharmaceutical industry, with at least 5 years focused on cell therapy, gene therapy, or complex biologics manufacturing. Demonstrated success leading or significantly contributing to phase-appropriate, risk-based quality systems in GMP environments (early development through commercialization). Hands-on or direct oversight experience in aseptic processing, sterile product manufacturing, cleanroom operations, and sterility assurance programs. Proven track record managing QA/QC for autologous or allogeneic cell products and/or viral-vector gene therapies. Prior experience at the Manager or Director level with direct reports and cross-functional influence. Skills & Competencies Thorough working knowledge of

U.S. GMP

regulations (21 CFR Parts 210/211, 600 series, and veterinary-specific guidance from FDA CVM), ICH guidelines, and risk-management principles. Strong analytical, problem-solving, and decision-making skills with the ability to balance speed and compliance in a fast-paced biotech setting. Excellent written and verbal communication; able to represent Quality in regulatory interactions and internal leadership forums. Passion for animal health and a collaborative, pragmatic leadership style. Preferred Qualifications Direct experience with veterinary biologics or FDA CVM-regulated products. Previous work in a startup or small-biotech environment. Professional certifications (e.g., ASQ CQA, CQE, or sterile manufacturing/aseptic processing training) are advantageous but not required. Location & Work Environment This is a full-time, on-site position based at our cGMP manufacturing facility. The role requires hands-on presence on the manufacturing floor during production campaigns, including occasional off-shift or weekend support as dictated by the manufacturing schedule. All duties will be performed in strict compliance with FDA regulations related to the manufacture of cell and gene therapy products for veterinary medicine, including current Good Manufacturing Practice (cGMP) and CVM-specific guidance. The Director of Quality plays a critical role in ensuring the safe, compliant, and reliable production of advanced veterinary therapies. We are an equal opportunity employer committed to advancing safe and effective veterinary cell and gene therapies in full accordance with FDA/CVM standards.

ABOUT GALLANT

Gallant is the leader in veterinary regenerative medicine on a mission to bring transformational "ready-to-use" stem cell therapies to pets everywhere that treat the root cause of disease. With five high value clinical stage programs in development and a platform that is generating additional therapies, the company is positioned for their first FDA conditional approval in 2026, bringing a new class of therapies to animal health. Gallant is a privately-held company and backed by top venture capital firms BOLD Capital, Digitalis Ventures, Hill Creek Partners and NovaQuest, and recently completed our Series B financing. We have onsite GMP manufacturing, R D and offices headquartered in La Jolla, CA. We offer a competitive base salary, generous health benefits, stock compensation, PTO, pet-friendly offices, and a virtual work environment as needed. We are a tight, incredibly smart and passionate team, deeply committed to our vision to bring "ready-to-use" stem cell therapies to pets worldwide.

Pay:

From $150,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Application Question(s): Can you tell us why you would be a good fit for this role?

Experience:

Quality experience in the biopharmaceutical industry: 8 years (Required)

Work Location:

In person