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Loyal

Director, Quality Systems and Compliance

Loyal

Director of Quality Systems ensuring FDA compliance for drug submissions at Loyal's veterinary medicine company. Building and administering the Quality Management System while leading assurance systems.

Posted 7/8/2026full-timeRemote • 🇺🇸 United StatesLead💰 $180,000 - $220,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in managing electronic Quality Management Systems (eQMS) with a focus on FDA-CVM regulatory compliance, GxP principles, and quality assurance practices. Proven ability to lead cross-functional teams, ensure documentation compliance, and drive continuous improvement in quality processes.

Highest-signal resume keywords
Electronic QMS AdministrationGxP ComplianceFDA Regulatory StandardsQuality Assurance LeadershipDocument Control Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Quality Management System (QMS)Computerized System Validation (CSV)Good Clinical Practice (GCP)Good Laboratory Practice (GLP)Good Manufacturing Practice (GMP)Validation Plan ReviewSOP DevelopmentRegulatory Inspection SupportProject ManagementRisk Assessment
Soft Skills
Exceptional Writing SkillsOrganizational SkillsCommunication SkillsInfluencing SkillsCross-Functional Collaboration
Tools & Technologies
Electronic QMS PlatformLearning Management System (LMS)
Industry Keywords
FDAEMAISO 9001VICHAnimal Health

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • 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.
  • 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.
  • Own the CSV/CSA program for GxP computerized systems, 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.
  • Partner with IT/GxP Systems and system owners to define validation requirements for new tools and integrations before go-live.

Requirements

What you’ll need
  • 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).
  • 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.

Benefits

Comp & perks
  • 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