Director, Quality Systems and Compliance

1 hour, 4 minutes ago
Full-time
Lead
Quality Assurance and Testing
Loyal

Loyal

Loyal is a clinical-stage biotechnology company based in San Francisco, California, founded in 2020. The company is dedicated to developing prescription drugs aimed at extending the healthy lifespan and improving the quality of life for dogs. Loyal focuses on preventive care by addressing age-associated diseases and metabolic dysfunction in dogs, particularly large breeds. The company is led by CEO Celine Halioua and has raised over $116.81 million in funding, with ongoing efforts to secure FDA approvals through its Center for Veterinary Medicine. Loyal's drug development pipeline includes three main products targeting longevity and healthy aging in dogs. LOY-002 is designed for senior dogs and aims to correct metabolic dysfunction, while LOY-001 and LOY-003 focus on correcting IGF-1 and growth hormone overexpression in large dogs. The company is conducting a nationwide clinical study called STAY, enrolling 1,300 senior dogs across 70 veterinary clinics. Loyal emphasizes partnerships with veterinary professionals for the administration of its products and conducts research involving DNA sequencing from canine saliva samples.

research
201-500
Founded 2020
$238M raised

Description

  • Build, maintain, and continuously improve the company’s Quality Management System (QMS).
  • Oversee GxP computerized systems validation and compliance across quality-related platforms.
  • Design, administer, and improve the electronic QMS, including access, workflows, validation status, and system health.
  • Manage document control processes for SOPs, forms, work instructions, policies, and other quality documents.
  • Author, review, approve, and maintain SOPs in collaboration with functional leaders.
  • Administer the training management system and ensure timely completion of required training.
  • Develop and implement onboarding, GxP, SOP, and compliance training programs.
  • Lead internal audits, inspection-readiness activities, and support regulatory inspections and partner audits.
  • Monitor quality metrics, prepare executive dashboards, and report compliance status to leadership.
  • Drive CAPA follow-up, closure, and continuous improvement across the organization.

Requirements

  • Bachelor’s degree in STEM or a related field, or equivalent work experience.
  • 10+ years of experience in quality assurance and compliance.
  • Hands-on experience administering an electronic QMS platform, including an LMS.
  • Strong working knowledge of QMS principles and GxP requirements, especially GCP/GLP and GMP.
  • Familiarity with regulatory standards including FDA, EMA, ISO 9001, and VICH.
  • Strong track record leading or supporting FDA/regulatory inspections.
  • Experience with animal health quality assurance is strongly preferred.
  • 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

  • Salary range of $180,000 to $220,000.
  • Full-coverage medical, dental, and vision insurance for employees and dependents.
  • $1,000 home office equipment stipend.
  • $1,200 annual learning budget for books, courses, and similar development expenses.
  • $250 monthly wellness budget for expenses such as gym, cleaners, spa, and food.
  • Unlimited vacation and paid holidays.
  • All 3-day weekends are turned into 4-day weekends.
  • Paw-ternity leave with a day off when you adopt a dog.
  • Company equity options grant for new hires.

Interested in this position?

Apply directly on the company website

Apply Now

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