VP, Quality Control & Analytical Development

About Loyal

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.

We’ve already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year.

Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.

About the role

The VP of QC & AD is responsible for the strategic leadership and execution of all analytical development and commercial quality control activities across Loyal’s pipeline and marketed products. This role owns the analytical and QC lifecycle from early development through commercialization, ensuring robust control strategies, regulatory compliance, and operational excellence for drug substance and drug product.

The VP of QC & AD will build and lead a scalable QC and analytical organization, establish fit-for-purpose operating models leveraging internal capabilities and external partners, and serve as a senior CMC thought partner to executive leadership. The role requires deep expertise in oral solid dosage (OSD) analytics, strong animal health regulatory acumen, and demonstrated success across early-stage, clinical, and commercial environments.

You will be reporting to our Chief Technical Operations Officer.

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 inspections.
• Select, manage, and govern external analytical laboratories, CDMOs (as applicable), and other partners to ensure technical performance, compliance, and cost effectiveness.
• Build, scale, and lead a high-performing QC and analytical development organization, including hiring, mentoring, and developing senior technical leaders.
• Establish operating models that balance internal capabilities with strategic outsourcing to support a growing and commercial portfolio.
• Manage resource planning, aligning analytical and QC investments with pipeline priorities and long-term business objectives.

About you

• Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline.
• 18+ years of progressive experience in analytical development and quality control for pharmaceutical products, with deep expertise in small-molecule oral solid dosage forms.
• Demonstrated experience spanning early development, clinical programs, commercial launch, and post-approval lifecycle management.
• Proven success building and leading analytical and/or QC organizations, including hiring, mentoring, and developing senior technical leaders.
• Extensive experience with analytical method development, phase-appropriate validation, method transfer, and GMP QC operations.
• Strong knowledge of animal health regulatory requirements, including FDA CVM and relevant global guidelines (e.g., VICH; ICH as applicable), with direct experience supporting regulatory submissions and inspections.
• Track record of effective oversight of external GMP testing laboratories and analytical service providers, including g