SVP, Quality Assurance, Compliance
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Job Description
SVP of Quality Assurance leading GxP quality management systems for a clinical-stage veterinary medicine company developing longevity drugs for dogs.
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.
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
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