Loyal 36

Senior Director, Quality Control & Analytical Development

Remote - USFull timeDirectorPosted 20 days ago
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About Loyal Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives. We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year. Loyal is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love. About the role The Senior Director of Quality Control & Analytical Development will be providing strategic leadership for all analytical development and commercial quality control across Loyal’s pipeline and marketed products. You will oversee the full QC lifecycle from early development through commercialization, ensuring robust control strategies, regulatory compliance, and operational excellence. Builds and scales the QC/AD organization, leveraging internal and external partners, with deep expertise in OSD analytics and animal health regulatory requirements. Your daily work will include Set and execute the global analytical development and quality control strategy aligned with Loyal’s corporate and CMC objectives. Own the end-to-end analytical and QC lifecycle from early development through commercialization, including commercial QC readiness, product release, stability programs, and post-approval lifecycle management. Serve as the accountable executive for GMP analytical and QC operations, ensuring inspection-ready systems and sustained regulatory compliance. Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions. Lead the development, validation, transfer, and lifecycle management of analytical methods and control strategies, with immediate focus on small-molecule oral solid dosage products, while supporting additional modalities as the pipeline evolves. Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies. Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers. Provide executive oversight of deviations, investigations, OOS/OOT events, and CAPAs related to analytical and QC activities. Serve as a senior analytical subject-matter expert in interactions with FDA Center for Veterinary Medicine (CVM) and other global animal health regulatory agencies, including regulatory submissions, responses, and...