Director, Quality Systems and Compliance

About Loyal Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives. We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year. Loyal is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love. About the role The Director, Quality Systems and Compliance is responsible for building, maintaining and continuously improving the company’s Quality Management System (QMS) and oversight of GxP CSV requirements to ensure compliance with applicable regulations, standards, and internal policies. This role oversees the development, implementation, and management of Standard Operating Procedures (SOPs), GxP Policies, company-wide training programs, GxP computerized systems implementation and maintenance, and quality compliance activities that support operational excellence and regulatory readiness. Responsible for building and leading cross-functional quality assurance systems across Loyal teams with an emphasis on FDA-CVM regulatory compliance for drug submissions and products. Duties/Responsibilities Quality Management System (QMS) Administration Own the design, administration, and continuous improvement of the electronic QMS, including validation status, user access, workflow configuration, and system health. Maintain, monitor, and continuously improve the company’s eQMS in alignment with GxP quality principles. Ensure eQMS documentation (e.g., SOPs, forms, work instructions, policies) is current, compliant, and effectively implemented across departments. Oversee document control processes, including drafting, reviewing, approving, and archiving quality documents. Drive periodic reviews and revisions of quality documents to ensure ongoing compliance and operational relevance. GxP Computer System Validation (CSV) Oversight Own the CSV/CSA program for GxP computerized systems (e.g., QMS, LIMS, eTMF, ERP modules touching GxP data), ensuring systems are validated commensurate with risk and intended use. Review and approve validation plans, protocols, and summary reports for new system implementations, upgrades, patches, and configuration changes. Ensure GxP systems maintain a validated state through periodic review, change control, and revalidation triggers. Partner with IT/GxP Systems and system owners to define validation requirements for new tools and integrations before go-live. Ensure computerized system controls support data integrity principles (ALCOA+), including audit trail review, access controls, and electronic signature compliance (21 CFR Part 11, Annex 11). SOP Development and Management Identify gaps or new operational areas requiring formalized procedures; determine when new SOPs or updates are needed. Author, review, and approve SOPs in collaboration with functional area leaders. Ensure SOPs are clear, practical, and aligned with applicable regulations and internal best practices. Manage the SOP lifecycle, including version control, obsolescence, and communication of updates. Training and Compliance Administer the company’s training management system, ensuring all staff receive and complete required training on time. Develop and implement training programs for onboarding, GxP, SOPs, and compliance topics. Track and report training completion metrics and maintain accurate training records. Collaborate with department heads to identify training needs and continuous improvement opportunities. Compliance Ensure quality systems and practices align with applicable regulations and standards (21 CFR Parts 210/211, 820, ICH Q9/Q10, EU GMP Annex 11/Chapter 7, as applicable). Lead internal audit and inspection-readiness programs; support hosting of regulatory inspections and partner audits. Monitor and interpret evolving regulatory guidance, translating requirements into practical quality system updates. corrective and preventive actions (CAPA) and ensure timely follow-up and closure. Monitor quality metrics and generate executive level dashboards and compliance reports for management review. Promote a culture of quality, integrity, and continuous improvement across the organization. Team building/Culture requirements Communicate with context, as this helps teams understand the guard rails around the quality process and why it matters. Ensure timeline requirements for Quality are communicated and included in project planning. Maintain a high level of attention to detail to ensure documents subject to the Quality review are internally and externally consistent. Design a Quality Assurance Unit program and system that is fit for purpose in the current company and can scale to a foreseeable future. Be a kind and considerate team member, especially where quality reviews make life harder for collaborating teams in house. Startup mindset: work fast, low ego, comfortable with uncertainty, and collaborative. About You Bachelor’s degree in STEM or related field or equivalent work experience. Minimum 10+ years of experience in quality assurance, compliance Hands-on experience administering an electronic QMS platform including LMS. Strong working knowledge of QMS principles, GxP requirements (especially GCP/GLP and GMP), and relevant regulatory standards (FDA, EMA, ISO 9001, VICH). Willing to familiarize yourself with regulatory practices in which you may not have experience. Strong track record leading or supporting FDA/regulatory inspections. Track record of success and a broad understanding of current QA practices as they apply to animal health and quality assurance. Exceptional writing, organizational, and communication skills. Proven ability to manage multiple projects and deadlines in a regulated environment. Ability to influence cross-functional teams and drive a culture of quality and compliance. Salary Range: $180,000 - $220,000 Loyal 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 Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Moonshots, derisked methodically Bringing the first longevity drug to market is an extremely difficult technical and social pursuit. To achieve this we must take bigger bets than the field has historically made, paired with the technical rigor to de-risk them step by step. We plan on both short and extremely long timescales, and we have the conviction to see our vision through to success or failure. Opportunity is at the intersection We lean into combining disciplines, expertise, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We push back on each other, ask questions instead of issuing orders, and try to prove ourselves wrong. We are emotionally attached to the outcome, not our personal hypotheses, and welcome being challenged instead of treating it as a threat. High agency, high humility Most of what we're doing has never been done before, so we can't rely on established precedents to guide our way. We move forward to generate clarity, build strategies resilient to the fact that we don't know what we don't know, and design small experiments where we can fail safely, without jeopardizing the bigger mission. Lead with transparency and context We proactively and consistently share the why behind our strategy - not just the what - because we believe sharing context enables great people to make great decisions. Empathy and respect for all life Our patients are not just numbers. We deeply respect the value of every life, large and small and take our ethical responsibility to the families we treat extremely seriously.