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Role Description

The SVP of Quality Assurance & Compliance is responsible for leading Loyal’s enterprise-wide Quality Management System (QMS) and ensuring compliance across GMP, GLP, and GCP activities supporting ongoing and future clinical programs, CMC development, and commercialization. This executive will drive sustained inspection readiness and regulatory excellence, including preparation for and successful execution of FDA Center for Veterinary Medicine (CVM) Pre-Approval Inspections (PAIs).

This role serves as the independent quality authority at the executive level, embedding risk management, data integrity, and a culture of quality across all GxP-regulated activities. The ideal candidate brings a demonstrated track record of leading organizations through regulatory inspections and building scalable, durable GxP systems in high-growth environments.

You will be reporting to our CEO.

Key Responsibilities

• Lead and continuously advance Loyal’s enterprise-wide GxP Quality Management System, ensuring compliance across GMP, GLP, and GCP domains.
• Drive sustained inspection readiness, including strategic preparation for FDA CVM Pre-Approval Inspections (PAIs) and other global regulatory inspections.
• Provide executive oversight of GCP quality systems, including clinical trial governance, CRO oversight, TMF compliance, protocol adherence, vendor qualification, and audit readiness for active and future studies.
• Ensure robust GMP oversight across CMC development, manufacturing partners, testing laboratories, and commercial supply activities.
• Oversee GLP compliance for pivotal laboratory-based studies and CROs.
• Lead enterprise audit strategy, including internal audits, supplier audits, clinical site audits, and mock regulatory inspections.
• Establish and maintain quality agreements and oversight frameworks for CDMOs, CROs, testing laboratories, and other GxP vendors.
• Provide executive oversight of deviations, investigations, CAPAs, change controls, and risk management processes to ensure timely and defensible resolution.
• Develop and monitor quality metrics and dashboards to provide executive visibility into compliance performance and organizational risk.
• Serve as the primary quality representative during regulatory inspections and interactions with FDA CVM and other global animal health authorities.
• Recruit, build, and lead a high-performing QA organization with scalable governance structures and clear accountability.
• Foster a proactive, risk-based quality culture that supports operational agility while maintaining regulatory rigor.

Qualifications

• 20+ years of progressive Quality Assurance leadership experience in regulated pharmaceutical or animal health environments.
• Demonstrated track record of successfully leading organizations through FDA regulatory inspections, including Pre-Approval Inspections (PAIs), with favorable outcomes.
• Proven experience designing, implementing, and maturing enterprise-wide GxP Quality Management Systems in startup or high-growth environments, supporting clinical development through commercialization.
• Deep expertise across GMP, GCP, and GLP quality systems, including CRO governance, clinical quality oversight, manufacturing oversight, and supplier qualification.
• Experience overseeing outsourced manufacturing, clinical vendors, and testing laboratories within a comprehensive GxP framework.
• Demonstrated ability to scale quality infrastructure in alignment with expanding clinical portfolios and commercial readiness.
• Executive presence with the ability to serve as an independent and credible quality authority at the leadership level.
• Experience building, mentoring, and scaling QA teams in dynamic, growth-oriented organizations.

Preferred Attributes

• Experience supporting first-time commercial launches.
• Experience in animal health or closely related regulated environments.
• Knowledge of FDA CVM requirements and relevant global guidelines.
• Experience leading organizations through significant growth, transformation, or quality system evolution.
• Strong systems-thinking mindset and disciplined, risk-based decision-making capabilities.

Benefits

• Full-coverage health insurance — medical, dental and vision — for you and your dependents.
• $1,000 home office equipment stipend.
• $1,200/year learning budget for books, courses, etc.
• $250/month wellness budget for gym, cleaners, spa, food, etc.
• All 3-day weekends are turned into 4-day weekends 🎉.
• Unlimited vacation and paid holidays.
• Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶.
• Competitive salary.
• Company equity options grant for new hires.