SVP, Quality Assurance, Compliance

Job Description: • 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. Requirements: • 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. 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 Apply tot his job Apply To this Job