Senior Director, Quality Control & Analytical Development

1 hour, 59 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

  • Set and execute the global analytical development and quality control strategy aligned with corporate and CMC objectives.
  • Own the end-to-end analytical and QC lifecycle from early development through commercialization, including product release, stability programs, and post-approval lifecycle management.
  • Serve as the accountable executive for GMP analytical and QC operations and maintain inspection-ready systems and regulatory compliance.
  • Lead development, validation, transfer, and lifecycle management of analytical methods and control strategies.
  • Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies.
  • Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers.
  • Provide executive oversight of deviations, investigations, OOS/OOT events, and CAPAs related to analytical and QC activities.
  • Serve as a senior analytical subject-matter expert in interactions with FDA CVM and other global animal health regulatory agencies.
  • Select, manage, and govern external analytical laboratories, CDMOs, and other partners to ensure technical performance, compliance, and cost effectiveness.
  • Build, scale, and lead a high-performing QC and analytical development organization, including hiring, mentoring, and developing senior technical leaders.
  • Establish operating models that balance internal capabilities with strategic outsourcing to support a growing commercial portfolio.
  • Manage resource planning and align analytical and QC investments with pipeline priorities and long-term business objectives.

Requirements

  • Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline.
  • 18+ years of progressive experience in analytical development and quality control for pharmaceutical products.
  • Deep expertise in small-molecule oral solid dosage forms.
  • Demonstrated experience across early development, clinical programs, commercial launch, and post-approval lifecycle management.
  • Proven success building and leading analytical and/or QC organizations, including hiring, mentoring, and developing senior technical leaders.
  • Extensive experience with analytical method development, phase-appropriate validation, method transfer, and GMP QC operations.
  • Strong knowledge of animal health regulatory requirements, including FDA CVM and relevant global guidelines such as VICH and ICH as applicable.
  • Direct experience supporting regulatory submissions and inspections.
  • Track record of effective oversight of external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution.
  • Strategic mindset with the ability to translate scientific and regulatory complexity into clear, actionable business recommendations.
  • Comfort operating in a fast-paced, growth-stage environment with both hands-on technical leadership and executive-level decision-making.
  • Excellent communication and influencing skills with executive leadership, regulators, and external partners.

Benefits

  • Salary range of $230,000 to $280,000.
  • Competitive salary.
  • Company equity options grant for new hires.
  • Full-coverage health insurance for you and your dependents, including medical, dental, and vision.
  • $1,000 home office equipment stipend.
  • $1,200 per year learning budget for books, courses, and similar development expenses.
  • $250 per month wellness budget for gym, cleaners, spa, food, and other wellness-related expenses.
  • Unlimited vacation and paid holidays, plus all 3-day weekends are turned into 4-day weekends.
  • Paw-ternity leave with a day off when you adopt a dog.

Interested in this position?

Apply directly on the company website

Apply Now

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