Quality Control Lead

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 . 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 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.

POSITION SUMMARY

The QC Lead will provide hands-on oversight of quality control activities to ensure that all data generated by internal laboratories and qualified third-party contract testing laboratories fully support clinical and commercial manufacturing of cell and gene therapy products regulated by the FDA Center for Veterinary Medicine (CVM). This role is critical to maintaining compliance with current Good Manufacturing Practice (CGMP) and all applicable FDA regulations governing the manufacture of veterinary cell and gene therapy products (21 CFR Parts 210,211, 600-680, and CVM-specific guidance). The incumbent will review, approve, and release analytical data, ensuring product safety, identity, purity, potency, and stability throughout the product lifecycle while driving continuous improvement in QC systems.

RESPONSIBILITIES

Review and approve analytical data packages generated by internal QC laboratories and third-party testing laboratories to support lot release, stability programs, and process validation for clinical and commercial manufacturing. Ensure that all QC data meet pre-established acceptance criteria, specifications, and regulatory requirements outlined in FDA/CVM guidance for cell and gene therapy products for veterinary use. Author, review, and approve QC-related SOPs, test methods, specifications, stability protocols, and deviation/OOS/OOT investigations in accordance with

FDA 21 CFR

211 and CVM expectations. Manage the qualification, oversight, and performance monitoring of third-party laboratories, including audit support, data integrity reviews, and contract laboratory agreements to guarantee compliance with CGMP and data integrity ALCOA+ principles. Support regulatory submissions (e.g., INAD, NADA, CMC sections) by compiling and verifying QC data packages for FDA/CVM review. Lead or participate in cross-functional teams for technology transfer, process validation, and comparability studies for cell and gene therapy manufacturing. Identify and implement QC process improvements, including automation, risk-based approaches, and digital data management systems while maintaining full traceability and compliance. Oversee trending analysis of CPP/CQA, environmental monitoring, OOT/OOS/deviation rate to proactively identify emerging quality risks, support manufacturing conformance, and drive timely investigations and CAPA. Prepare for and support FDA/CVM inspections, including hosting audits, responding to observations, and implementing corrective/preventive actions (CAPA). Provide technical guidance and training to QC analysts, manufacturing, and quality assurance personnel on cGMP and cell/gene therapy-specific requirements. Maintain current knowledge of evolving FDA/CVM regulations, guidance documents, and industry best practices for veterinary advanced therapies.

QUALIFICATIONS

Bachelor's degree in biology, biochemistry, molecular biology, or related science. Minimum 8 years of progressive QC experience in a cGMP-regulated environment, with at least 4 years in a managerial or supervisory role. Demonstrated expertise in reviewing and approving complex analytical data from both internal and external laboratories to support clinical and commercial product release. In-depth working knowledge of FDA regulations (21 CFR Parts 210/211 and relevant biologics regulations) and direct experience supporting regulatory inspections. Strong understanding of analytical methods used in cell and gene therapy testing (e.g., qPCR, flow cytometry, ELISA, cell-based potency assays, NGS, sterility, and mycoplasma testing). Proven ability to manage multiple priorities in a fast-paced, regulated manufacturing setting with strict attention to data integrity and compliance. Excellent technical writing, verbal communication, and cross-functional collaboration skills.

MOST IMPORTANT QUALITIES

Strong communication skills, both written and verbal Easily adapts to change, enjoys a dynamic environment Willingness to learn High integrity, genuine Entrepreneurial spirit Remarkable discipline and organization Great attention to detail High speed of execution Strong work ethic Resourcefulness, ability to get things done on your own despite obstacles Ability to receive and incorporate feedback Passion for service Great at conflict resolution Consistently positive attitude Loves cats, dogs and horses!

WORK ENVIRONMENT

This position is based at our GMP manufacturing facility and requires on-site presence to support real-time data review and manufacturing operations. Occasional travel to third-party laboratories or regulatory meetings may be required. 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 QC Manager is accountable for safeguarding product quality and patient (animal) safety through rigorous, regulation-driven quality oversight. We are an equal opportunity employer committed to advancing safe and effective veterinary cell and gene therapies in full accordance with FDA/CVM standards.

JOB TYPE

Full-time Pay:

$80,000.00 - $95,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Application Question(s): Tell us how you fit this role.

Experience:

progressive QC in a cGMP-regulated environment: 8 years (Preferred)

Work Location:

In person