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 Now
Apply Now