About the roleThe 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/ResponsibilitiesQuality 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
