Senior Director, Quality Control & Analytical Development

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.

Reports to: Chief Technical Operations Officer

About the Role

The Senior Director of Quality Control and Analytical Development is responsible for the strategic leadership and hands-on execution of all analytical development and QC activities across Loyal's pipeline and marketed products. This role owns the analytical and QC lifecycle from early development through commercialization, building the function, writing and reviewing key documents, and ensuring robust control strategies, regulatory compliance, and operational excellence for drug substance and drug product.

This is a deeply hands-on role. Loyal is a lean, virtual company. This person will both set the strategy and do the work, from authoring CTD analytical sections to qualifying contract testing laboratories. The immediate focus is analytical development and QC for small molecule OSD, in support of NADA resubmission and PAI readiness, while building the foundation for a commercial QC operation.

This person will build and lead a scalable AD and QC organization, establish fit-for-purpose operating models leveraging external partners, and serve as a senior CMC thought partner to the CTOO and executive leadership.

Your Daily Work Will Include

• Set and execute the analytical development and QC strategy aligned with Loyal's CMC objectives, resubmission timeline, and PAI readiness
• Own the end-to-end analytical and QC lifecycle from early development through commercialization, including method development and validation, commercial QC readiness, product release, stability programs, and post-approval lifecycle management
• Author and review analytical sections of regulatory submissions, including CTD modules, NADA/resubmission CMC sections, responses to agency observations, and amendments; this person writes, not just reviews
• Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies for drug substance and drug product
• Lead the development, validation, transfer, and lifecycle management of analytical methods with immediate focus on small molecule OSD, while supporting additional modalities as the pipeline evolves
• Own method transfers from development to QC and from internal to contract testing laboratories; ensure methods are robust, transfer-ready, and fit for GMP use
• Qualify, manage, and govern contract testing laboratories, including identifying and qualifying alternative testing labs to ensure capability and capacity are not single-source dependent
• Ensure contract lab reference standard oversight is governed appropriately, including qualification, traceability, and lifecycle management at external partners
• Serve as the accountable leader for GMP analytical and QC operations, ensuring inspection-ready systems and sustained regulatory compliance; own PAI readiness for all analytical and QC activities
• Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers
• Provide oversight of deviations, investigations, OOS/OOT events, change control, and CAPAs related to analytical and QC activities
• Serve as the senior analytical subject matter expert in interactions with FDA CVM and other global animal health regulatory agencies, including regulatory submissions, responses, and inspections
• Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions
• Build, scale, and lead a high-performing AD and QC organization, including hiring, mentoring, and developing senior technical staff
• Own and oversee analytical data systems, ensuring data integrity, 21 CFR Part 11 compliance, and robust digital infrastructure across internal and